Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable CAD in Post MI Patients

NCT ID: NCT01866904

Last Updated: 2018-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

9284 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-19

Study Completion Date

2017-03-31

Brief Summary

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THis study is intended to provide contemporary data on the burden of disease in patients 1 to 3 years post-MI, including a description of patient characteristics, current treatment patterns, rate of major CV events, and healthcare resource utilization in a 'real world' patient population at high atherothrombotic risk.

Detailed Description

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TIGRIS is a multinational, multi-centre, observational, prospective, longitudinal cohort study which will include stable CAD patients with history of MI 1-3 years ago and high risk of developing atherothrombotic events in a real world setting. The follow-up period is 3 years.

Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. Patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the study.

Conditions

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Stable Coronary Artery Disease (CAD), Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stable CAD patients aged 50 years or older

Stable CAD patients aged 50 years or older with documented history of presumed spontaneous MI with their most recent MI occurring 1 to 3 years prior to enrollment and have at least 1 additional risk factor

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- Stable CAD patients aged 50 years or older with documented history of presumed spontaneous MI with their most recent MI occurring 1 to 3 years prior to enrollment and have at least 1 of the following risk factors: age ≥ 65 years; diabetes mellitus requiring medication; documented history of a second prior presumed spontaneous MI (\>1 year ago); documented history of angiographic evidence of multivessel coronary artery disease; chronic renal dysfunction.

Exclusion Criteria

* Presence of serious co-morbidities in the opinion of the investigator which may limit life expectancy (\<1 year)
* Current participation in a blinded randomized clinical trial.
* Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient
* Patients receiving treatment of ticagrelor beyond 12 months, or off label use of ticagrelor.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lin Zhang, M.D., PhD

Role: STUDY_CHAIR

AstraZeneca GMA

David Brieger, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Concord Repatriation General Hospital

Locations

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Huntsville, Alabama, United States

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Los Angeles, California, United States

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Santa Ana, California, United States

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Torrance, California, United States

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Ventura, California, United States

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Clearwater, Florida, United States

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Miami, Florida, United States

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Tallahassee, Florida, United States

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Tucker, Georgia, United States

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Arlington Heights, Illinois, United States

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Englewood, Illinois, United States

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Lebanon, Indiana, United States

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Auburn, Maine, United States

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Bangor, Maine, United States

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Columbia, Maryland, United States

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Jackson, Michigan, United States

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Minneapolis, Minnesota, United States

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Manhasset, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Sandusky, Ohio, United States

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Abington, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Providence, Rhode Island, United States

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Jackson, Tennessee, United States

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Houston, Texas, United States

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Plano, Texas, United States

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Burlington, Vermont, United States

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Falls Church, Virginia, United States

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Manassas, Virginia, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Buenos Aires, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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Mendoza, , Argentina

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Salta, , Argentina

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Santa Fe, , Argentina

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Coffs Harbour, New South Wales, Australia

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Concord, New South Wales, Australia

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Kogarh, New South Wales, Australia

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Liverpool, New South Wales, Australia

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Newcastele, New South Wales, Australia

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St Leonards, New South Wales, Australia

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Wollongong, New South Wales, Australia

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Brisbane, Queensland, Australia

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Nambour, Queensland, Australia

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Southport, Queensland, Australia

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Woolloongabba, Queensland, Australia

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Epping, Victoria, Australia

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Parkville, Victoria, Australia

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Richmond, Victoria, Australia

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Fremantle, Western Australia, Australia

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Nedlands, Western Australia, Australia

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Aalst, , Belgium

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Bonheiden, , Belgium

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Brasschaat, , Belgium

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Brussels, , Belgium

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Genk, , Belgium

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Ghent, , Belgium

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Kortrijk, , Belgium

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Ostend, , Belgium

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Overpelt, , Belgium

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Veurne, , Belgium

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Campo Grande, Mato Grosso do Sul, Brazil

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Blumenal, Santa Cantarina, Brazil

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Marília, São Paulo, Brazil

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São José do Rio Preto, São Paulo, Brazil

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Saint John, New Brunswick, Canada

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Brampton, Ontario, Canada

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Cambridge, Ontario, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Newmarket, Ontario, Canada

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North York, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Thetford-Mines, Quebec, Canada

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Québec, , Canada

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Beijing, Beijing Municipality, China

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Chongqing, Chongqing Municipality, China

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Lanzhou, Gansu, China

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Guangzhou, Guangdong, China

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Nanjing, Jiangsu, China

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Wuxi, Jiangsu, China

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Zhenjiang, Jiangsu, China

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Changchun, Jilin, China

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Jinzhou, Liaoning, China

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Jinan, Shandong, China

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Shanghai, Shanghai Municipality, China

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Xian, Shanxi, China

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Taiyuan, Shanyuan, China

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Tianjin, Tianjin Municipality, China

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Kunming, Yunnan, China

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Medellín, Antioquia, Colombia

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Barranquilla, Atlántico, Colombia

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Cartagena, Caldas Department, Colombia

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Manizales, Caldas Department, Colombia

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Bucaramanga, Santander Dept, Colombia

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Cali, Valle del Cauca Department, Colombia

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Aalborg, , Denmark

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Arhus N, , Denmark

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Copenhagen, , Denmark

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Haderslev, , Denmark

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Hellerup, , Denmark

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København NV, , Denmark

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København S, , Denmark

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Randers, , Denmark

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Jyväskylä, , Finland

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Rovaniemi, , Finland

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Tampere, , Finland

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Turku, , Finland

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Abbeville, , France

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Arras, , France

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Boulogne-Billancourt, , France

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Briis Sous Forge, , France

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Corbeille Essone, , France

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Dijon, , France

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La Rochelle, , France

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Langres, , France

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Le Chesnay, , France

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Le Coudray, , France

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Lyon, , France

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Marseille, , France

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Nice, , France

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Roubaix, , France

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Salouël, , France

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Toulouse, , France

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Berlin, , Germany

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Bochum, , Germany

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Chemnitz, , Germany

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Cloppenburg, , Germany

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Coburg, , Germany

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Cologne, , Germany

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Dresden, , Germany

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Erfurt, , Germany

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Erlangen, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Frankfurt M, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Kiel, , Germany

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Koblenz, , Germany

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Leipzig, , Germany

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Leverkusen, , Germany

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Ludwigshafen, , Germany

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Lübeck, , Germany

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Mainz, , Germany

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Merseburg, , Germany

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Mönchengladbach, , Germany

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München, , Germany

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Potsdam, , Germany

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Soltau, , Germany

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Stuttgart, , Germany

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Ulm, , Germany

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Hyderabad, Andhra Pradesh, India

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Surat, Gujarat, India

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Bangalore, Karnataka, India

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Thrisur, Kerala, India

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Trivandrum, Kerala, India

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Indore, Madhya Pradesh, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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New Delhi, National Capital Territory of Delhi, India

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Mohali, Punjab, India

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Jaipur, Rajasthan, India

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Chennai, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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Noida, Uttar Pradesh, India

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Kolkata, West Bengal, India

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Ancona, , Italy

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Bologna, , Italy

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Catania, , Italy

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Lagosanto FE, , Italy

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Lido di Camaiore, , Italy

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Massa Carrara, , Italy

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Milan, , Italy

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Napoli, , Italy

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Nuoro, , Italy

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Palermo, , Italy

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Perugia, , Italy

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Prato, , Italy

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Sassari, , Italy

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Treviso, , Italy

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Toyoake-shi, Aichi-ken, Japan

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Chiba, Chiba, Japan

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Kisarazu-shi, Chiba, Japan

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Matsuyama, Ehime, Japan

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Fukui-shi, Fukui, Japan

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Fukuoka, Fukuoka, Japan

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Kurume-shi, Fukuoka, Japan

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Maebashi, Gunma, Japan

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Hiroshima, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Tomakomai-shi, Hokkaido, Japan

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Amagasaki-shi, Hyōgo, Japan

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Kanazawa, Ishikawa-ken, Japan

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Morioka, Iwate, Japan

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Isehara-shi, Kanagawa, Japan

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Sagamihara-shi, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Kochi, Kochi, Japan

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Kumamoto, Kumamoto, Japan

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Sendai, Miyagi, Japan

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Tenri-shi, Nara, Japan

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Hirakata-shi, Osaka, Japan

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Osaka, Osaka, Japan

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Suita-shi, Osaka, Japan

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Kusatsu-shi, Shiga, Japan

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Izunokuni-shi, Shizuoka, Japan

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Shizuoka, Shizuoka, Japan

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Komatsujima-shi, Tokushima, Japan

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Bunkyo-ku, Tokyo, Japan

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Chuo-Ku, Tokyo, Japan

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Wakayama, Wakayama, Japan

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Torreón, Coahuila, Mexico

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Tijuana, Estado de Baja California, Mexico

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Querétaro City, Querétaro, Mexico

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Toluca, State of Mexico, Mexico

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Chihuahua City, , Mexico

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Oaxaca City, , Mexico

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Puebla City, , Mexico

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San Luis Potosí City, , Mexico

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Amsterdam, , Netherlands

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Arnhem, , Netherlands

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Blaricum, , Netherlands

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Delft, , Netherlands

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Doetinchem, , Netherlands

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Ede, , Netherlands

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Groningen, , Netherlands

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Haarlem, , Netherlands

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Hardenberg, , Netherlands

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Heerlen, , Netherlands

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Hoofddorp, , Netherlands

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Hoogeveen, , Netherlands

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IJssel, , Netherlands

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Meppel, , Netherlands

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Sittard-Geleen, , Netherlands

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The Hague, , Netherlands

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Zutphen, , Netherlands

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Fredrikstad, , Norway

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Oslo, , Norway

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Stavanger, , Norway

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Braga, , Portugal

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Canelas, , Portugal

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Faro, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Senhora da Hora, , Portugal

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Setúbal, , Portugal

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Viana do Castelo, , Portugal

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Arad, , Romania

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Brăila, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Craiova, , Romania

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Drobeta-Turnu Severin, , Romania

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Focşani, , Romania

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Piteşti, , Romania

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Sibiu, , Romania

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Slatina, , Romania

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Timișoara, , Romania

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Chungcheongbuk-do, Cheongju-si, South Korea

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Wŏnju, Gangwon-do, South Korea

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Jinju, Gyeongsangnam-do, South Korea

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Jeonju, Jeollabuk-do, South Korea

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Gwangju, Jeollanam-do, South Korea

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Daejeon, Jung-gu, South Korea

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Daegu, Nam-gu, South Korea

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Busan, Seo-gu, South Korea

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Seoul, Sudogwon, South Korea

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Seville, Andalusia, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Toledo, Castille-La Mancha, Spain

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Barcelona, Catalonia, Spain

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Vic, Catalonia, Spain

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Cáceres, Extremadura, Spain

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Santiago de Compostela, Galicia, Spain

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Baza, Granada, Spain

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Alicante, , Spain

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Almería, , Spain

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Granada, , Spain

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Lleida, , Spain

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Madrid, , Spain

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Murcia, , Spain

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Ankara, , Turkey (Türkiye)

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Aydin, , Turkey (Türkiye)

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Diyarbak?r, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Merkez, , Turkey (Türkiye)

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Mersin, , Turkey (Türkiye)

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Airdrie, , United Kingdom

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Cambridge, , United Kingdom

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East Kilbride, , United Kingdom

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London, , United Kingdom

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Portadown, , United Kingdom

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Sheffield, , United Kingdom

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Taunton, , United Kingdom

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Wolverhampton, , United Kingdom

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Valencia, Carabobo, Venezuela

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Caracas, Miranda, Venezuela

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Countries

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United States Argentina Australia Belgium Brazil Canada China Colombia Denmark Finland France Germany India Italy Japan Mexico Netherlands Norway Portugal Romania South Korea Spain Turkey (Türkiye) United Kingdom Venezuela

References

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Krishnamurthy SN, Pocock S, Kaul P, Owen R, Goodman SG, Granger CB, Nicolau JC, Simon T, Westermann D, Yasuda S, Andersson K, Brandrup-Wognsen G, Hunt PR, Brieger DB, Cohen MG. Comparing the long-term outcomes in chronic coronary syndrome patients with prior ST-segment and non-ST-segment elevation myocardial infarction: findings from the TIGRIS registry. BMJ Open. 2023 Dec 18;13(12):e070237. doi: 10.1136/bmjopen-2022-070237.

Reference Type DERIVED
PMID: 38110389 (View on PubMed)

Nicolau JC, Owen R, Furtado RHM, Goodman SG, Granger CB, Cohen MG, Westermann D, Yasuda S, Simon T, Hedman K, Hunt PR, Brieger DB, Pocock SJ. Long-term outcomes among stable post-acute myocardial infarction patients living in rural versus urban areas: insights from the prospective, observational TIGRIS registry. Open Heart. 2023 Aug;10(2):e002326. doi: 10.1136/openhrt-2023-002326.

Reference Type DERIVED
PMID: 37604649 (View on PubMed)

Bagai A, Ali FM, Gregson J, Alexander KP, Cohen MG, Sundell KA, Simon T, Westermann D, Yasuda S, Brieger D, Goodman SG, Nicolau JC, Granger CB, Pocock S. Multimorbidity, functional impairment, and mortality in older patients stable after prior acute myocardial infarction: Insights from the TIGRIS registry. Clin Cardiol. 2022 Dec;45(12):1277-1286. doi: 10.1002/clc.23915. Epub 2022 Nov 1.

Reference Type DERIVED
PMID: 36317424 (View on PubMed)

Carnicelli AP, Owen R, Pocock SJ, Brieger DB, Yasuda S, Nicolau JC, Goodman SG, Cohen MG, Simon T, Westermann D, Hedman K, Andersson Sundell K, Granger CB. Atrial fibrillation and clinical outcomes 1 to 3 years after myocardial infarction. Open Heart. 2021 Dec;8(2):e001726. doi: 10.1136/openhrt-2021-001726.

Reference Type DERIVED
PMID: 34911791 (View on PubMed)

Russo JJ, Yan AT, Pocock SJ, Brieger D, Owen R, Sundell KA, Bagai A, Granger CB, Cohen MG, Yasuda S, Nicolau JC, Brandrup-Wognsen G, Westermann D, Simon T, Goodman SG. Determinants of long-term dual antiplatelet therapy use in post myocardial infarction patients: Insights from the TIGRIS registry. J Cardiol. 2022 Apr;79(4):522-529. doi: 10.1016/j.jjcc.2021.10.024. Epub 2021 Nov 29.

Reference Type DERIVED
PMID: 34857432 (View on PubMed)

Pocock S, Brieger DB, Owen R, Chen J, Cohen MG, Goodman S, Granger CB, Nicolau JC, Simon T, Westermann D, Yasuda S, Hedman K, Mellstrom C, Andersson Sundell K, Grieve R. Health-related quality of life 1-3 years post-myocardial infarction: its impact on prognosis. Open Heart. 2021 Feb;8(1):e001499. doi: 10.1136/openhrt-2020-001499.

Reference Type DERIVED
PMID: 33563776 (View on PubMed)

Nicolau JC, Brieger D, Owen R, Furtado RHM, Goodman SG, Cohen MG, Simon T, Westermann D, Granger CB, Grieve R, Yasuda S, Chen J, Hedman K, Mellstrom C, Brandrup-Wognsen G, Pocock SJ. Diabetes association with self-reported health, resource utilization, and prognosis post-myocardial infarction. Clin Cardiol. 2020 Dec;43(12):1352-1361. doi: 10.1002/clc.23476. Epub 2020 Nov 4.

Reference Type DERIVED
PMID: 33146924 (View on PubMed)

Westermann D, Goodman SG, Nicolau JC, Requena G, Maguire A, Chen JY, Granger CB, Grieve R, Pocock SJ, Blankenberg S, Vega AM, Yasuda S, Simon T, Brieger D; TIGRIS Study Investigators. Rationale and design of the long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients (TIGRIS) study. Clin Cardiol. 2017 Dec;40(12):1197-1204. doi: 10.1002/clc.22837. Epub 2017 Dec 16.

Reference Type DERIVED
PMID: 29247524 (View on PubMed)

Goodman SG, Nicolau JC, Requena G, Maguire A, Blankenberg S, Chen JY, Granger CB, Grieve R, Pocock SJ, Simon T, Yasuda S, Vega AM, Brieger D; TIGRIS Study Investigators. Longer-term oral antiplatelet use in stable post-myocardial infarction patients: Insights from the long Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease (TIGRIS) observational study. Int J Cardiol. 2017 Jun 1;236:54-60. doi: 10.1016/j.ijcard.2017.02.062. Epub 2017 Feb 21.

Reference Type DERIVED
PMID: 28268087 (View on PubMed)

Related Links

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Other Identifiers

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NIS-CMC-DUM-2013/1

Identifier Type: -

Identifier Source: org_study_id

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