Clinical, Physiological and Prognostic Implication of Microvascular Status

NCT ID: NCT02186093

Last Updated: 2017-11-27

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

UNKNOWN

Total Enrollment

1197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2020-11-30

Brief Summary

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There are several physiologic parameters in evaluating cardiovascular disease. This study will reveal which parameter is the most proper value in predicting disease severity and risk factors of patients.

Detailed Description

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Fractional Flow Reserve (FFR), index of microcirculatory resistance (IMR), and coronary flow reserve (CFR) will be measured in stable angina patients before coronary intervention.

Relationship between angiographic characteristics of patients and FFR, IMR, CFR will be analyzed. Comparison of risk factors and prognosis between parameters will be also analyzed. This study will evaluate that which parameter is correlate with disease severity and risk factors of patients.

Conditions

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Coronary Artery Disease

Keywords

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Coronary Artery Disease Angina, Stable Fractional Flow Reserve, Myocardial Coronary Angiography

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Korea

patients in South of Korea

No interventions assigned to this group

United Kingdom

patients in England

No interventions assigned to this group

Spain

patients in Spain

No interventions assigned to this group

United State of America

patients in USA

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18
* Patients with stable angina
* FFR, IMR, CFR were measured before coronary intervention

Exclusion Criteria

* Patients who have severe side effects or contraindication to hyperemic agents (ex. adenosine)
* Patients with hemodynamic instability
* elevation of cardiac enzymes, evidence of acute MI, or a culprit vessel of acute coronary syndrome
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ulsan University Hospital

OTHER

Sponsor Role collaborator

Keimyung University

OTHER

Sponsor Role collaborator

Inje University

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

University of Glasgow

OTHER

Sponsor Role collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role collaborator

Royal Prince Alfred Hospital, Sydney, Australia

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bon-Kwon Koo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul national university hosptial

Joo Myung Lee, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Keimyung University Dongsan medical center

Daegu, , South Korea

Site Status COMPLETED

Inje University Ilsan Paik Hospital

Goyang, , South Korea

Site Status COMPLETED

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Ulsan University Hospital, University of Ulsan College of Medicine

Ulsan, , South Korea

Site Status COMPLETED

Countries

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South Korea

Central Contacts

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Joo Myung Lee, MD, MPH, PhD

Role: CONTACT

Phone: 82-10-8884-8439

Email: [email protected]

Bon-Kwon Koo, MD, PhD

Role: CONTACT

Phone: 82-2-2072-2062

Email: [email protected]

Facility Contacts

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Bon-Kwon Koo, MD, PhD

Role: primary

Joo Myung Lee, MD, MPH, PhD

Role: primary

References

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Chung JH, Lee KE, Lee JM, Her AY, Kim CH, Choi KH, Song YB, Hahn JY, Kim HY, Choi JH, Garg S, Doh JH, Nam CW, Koo BK, Shin ES. Effect of Sex Difference of Coronary Microvascular Dysfunction on Long-Term Outcomes in Deferred Lesions. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1669-1679. doi: 10.1016/j.jcin.2020.04.002. Epub 2020 Jun 24.

Reference Type DERIVED
PMID: 32593698 (View on PubMed)

Hoshino M, Hamaya R, Kanaji Y, Kanno Y, Hada M, Yamaguchi M, Sumino Y, Hirano H, Horie T, Usui E, Sugiyama T, Murai T, Lee T, Yonetsu T, Lee JM, Choi KH, Hwang D, Park J, Jung JH, Kim HY, Jung HW, Cho YK, Yoon HJ, Song YB, Hahn JY, Doh JH, Nam CW, Shin ES, Hur SH, Mejia-Renteria H, Lauri F, Goto S, Macaya F, McInerney A, Gravina G, Vera R, Gonzalo N, Jimenez-Quevedo P, Nunez-Gil I, Salinas P, Nombela-Franco L, Del Trigo M, Fernandez-Ortiz A, Macaya C, Koo BK, Escaned J, Kakuta T. Sex Differences in Long-Term Outcomes in Patients With Deferred Revascularization Following Fractional Flow Reserve Assessment: International Collaboration Registry of Comprehensive Physiologic Evaluation. J Am Heart Assoc. 2020 Feb 18;9(4):e014458. doi: 10.1161/JAHA.119.014458. Epub 2020 Feb 17.

Reference Type DERIVED
PMID: 32063120 (View on PubMed)

Lee SH, Choi KH, Lee JM, Hwang D, Rhee TM, Park J, Kim HK, Cho YK, Yoon HJ, Park J, Song YB, Hahn JY, Doh JH, Nam CW, Shin ES, Hur SH, Koo BK. Physiologic Characteristics and Clinical Outcomes of Patients With Discordance Between FFR and iFR. JACC Cardiovasc Interv. 2019 Oct 28;12(20):2018-2031. doi: 10.1016/j.jcin.2019.06.044. Epub 2019 Sep 25.

Reference Type DERIVED
PMID: 31563683 (View on PubMed)

Lee JM, Choi KH, Hwang D, Park J, Jung JH, Kim HY, Jung HW, Cho YK, Yoon HJ, Song YB, Hahn JY, Doh JH, Nam CW, Shin ES, Hur SH, Koo BK. Prognostic Implication of Thermodilution Coronary Flow Reserve in Patients Undergoing Fractional Flow Reserve Measurement. JACC Cardiovasc Interv. 2018 Aug 13;11(15):1423-1433. doi: 10.1016/j.jcin.2018.05.005.

Reference Type DERIVED
PMID: 30093048 (View on PubMed)

Lee JM, Jung JH, Hwang D, Park J, Fan Y, Na SH, Doh JH, Nam CW, Shin ES, Koo BK. Coronary Flow Reserve and Microcirculatory Resistance in Patients With Intermediate Coronary Stenosis. J Am Coll Cardiol. 2016 Mar 15;67(10):1158-1169. doi: 10.1016/j.jacc.2015.12.053.

Reference Type DERIVED
PMID: 26965536 (View on PubMed)

Lee JM, Layland J, Jung JH, Lee HJ, Echavarria-Pinto M, Watkins S, Yong AS, Doh JH, Nam CW, Shin ES, Koo BK, Ng MK, Escaned J, Fearon WF, Oldroyd KG. Integrated physiologic assessment of ischemic heart disease in real-world practice using index of microcirculatory resistance and fractional flow reserve: insights from the International Index of Microcirculatory Resistance Registry. Circ Cardiovasc Interv. 2015 Nov;8(11):e002857. doi: 10.1161/CIRCINTERVENTIONS.115.002857.

Reference Type DERIVED
PMID: 26499500 (View on PubMed)

Other Identifiers

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1404-057-573

Identifier Type: -

Identifier Source: org_study_id