Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes

NCT ID: NCT01353612

Last Updated: 2020-02-24

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

COMPLETED

Total Enrollment

1626 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-12-31

Brief Summary

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This is a prospective, multi-center imaging study expecting to enroll approximately 1350 patients scheduled for clinically-indicated coronary angiography. Following informed consent, patient will undergo baseline coronary intravascular ultrasound (IVUS) imaging and non-invasive ultrasound imaging of their carotid arteries. Following a 2-year follow-up period, patients will undergo repeat coronary IVUS and standard invasive coronary angiography as well as carotid ultrasound examination.

Additionally, patients will be contacted by phone on an annual basis for 5 years to collect cardiovascular and cerebrovascular clinical endpoints. Evaluations of plaque burden will be made using invasive and non invasive imaging tools in order to assess correlations between vascular beds, imaging technologies and main cardiovascular events.

Detailed Description

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CTA and PET Substudy:

A subset of patients enrolled into the main CAIN3 study will undergo a CTA. At sites where both CTA and PET imaging modalities exist, patients will be asked to undergo both tests. The CTA and PET scans can be done separately on 2 imaging beds on different days or performed on the same imaging bed, resulting in a combined CTA and PET scan being done in one scheduled visit. All imaging will be done within 90 days after the follow up IVUS.

The choice of radiotracer used (NaF or FDG) for PET imaging will be dependent upon site and availability on the day of the scan. A total of 120 patients will be enrolled in this substudy with approximately 50-60 undergoing CTA and PET.

Conditions

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Atherosclerosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Male and female patients over the age of 18 years.
* Patients scheduled for clinically indicated coronary angiography and possible ad hoc percutaneous coronary intervention (PCI) will be evaluated before their scheduled procedure.
* Written informed consent (approved by the Institutional Review Board \[IRB\]/Independent Ethics Committee \[IEC\]) obtained prior to any study specific procedures.
* Patients considered to be stable at enrollment (at the discretion of the investigator) are eligible provided they meet all other entry criteria.
* Angiogram meeting qualifying criteria

Exclusion Criteria

* Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for \>12 months) who refuse to undergo a urine or serum pregnancy test immediately prior to baseline and repeat imaging evaluations The urine or serum pregnancy test must be negative prior to imaging evaluations.
* Previous coronary artery bypass graft (CABG) surgery or probable need for CABG in the next 24 months.
* Patients who have symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] Class III or IV) at baseline.
* Patients with clinically significant valvular heart disease likely to require surgical repair or replacement during the treatment period of the study
* Any clinically significant medical condition or presence of any laboratory abnormality that is considered by the investigator to be clinically important and could interfere with the conduct of the study.
* The presence of severe liver disease as defined by the presence of cirrhosis, chronic active hepatitis, or chronic jaundice with hyperbilirubinemia,
* Patients with eGFR \< 45 ml/min prior to baseline imaging procedures, or with nephrotic syndrome
* Patients with a life expectancy less than 2 years.
* History of malignancy (except for curatively treated basal cell or squamous cell carcinoma of the skin) during the 3 years prior to the screening.
* Unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Canadian Atherosclerosis Imaging Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Claude Tardif, MD

Role: STUDY_CHAIR

Montreal Heart Institute

Locations

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Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Foothills Medical Centre

Calgary, British Columbia, Canada

Site Status

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Interventional Cardiology Research, St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Victoria Heart Institute Foundation

Victoria, British Columbia, Canada

Site Status

John Health Science Center

St. John's, Newfoundland and Labrador, Canada

Site Status

Queen Elizabeth II - Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Cambridge Cardiac Care

Cambridge, Ontario, Canada

Site Status

McMaster Clinic Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

St-Mary's Hospital

Kitchener, Ontario, Canada

Site Status

KMH Cardiology & Diagnostics Centre

Kitchener, Ontario, Canada

Site Status

London Health Sciences Center

London, Ontario, Canada

Site Status

KMH Cardiology & Diagnostics Centre

Mississauga, Ontario, Canada

Site Status

Southlake Regional Health Center

Newmarket, Ontario, Canada

Site Status

Heart Care Research

Oshawa, Ontario, Canada

Site Status

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Scarborough Cardiology Research

Scarborough Village, Ontario, Canada

Site Status

Sunnybrook Health Science Center

Toronto, Ontario, Canada

Site Status

University Health Network

Toronto, Ontario, Canada

Site Status

Complexe Hospitalier de la Sagamie

Chicoutimi, Quebec, Canada

Site Status

CHUS-Hopital Fleurimont

Fleurimont, Quebec, Canada

Site Status

CSSS-Hopital de Gatineau, secteur Hull

Gatineau, Quebec, Canada

Site Status

Viacar Recherche Clinique

Greenfield Park, Quebec, Canada

Site Status

CSSS de Laval

Laval, Quebec, Canada

Site Status

Hopital Pierre Boucher

Longueuil, Quebec, Canada

Site Status

Montreal Heart Institute

Montreal, Quebec, Canada

Site Status

CHUM Hopital-Hôtel-Dieu

Montreal, Quebec, Canada

Site Status

CUSM Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Hopital Sacré-Cœur de Montreal

Montreal, Quebec, Canada

Site Status

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

Site Status

Centre Hospitalier Régional de Lanaudière

Saint-Charles-Borromée, Quebec, Canada

Site Status

Centre de santé et des services sociaux de Beauce

Saint-Georges, Quebec, Canada

Site Status

St-Jerome Medical Research Inc.

Saint-Jérôme, Quebec, Canada

Site Status

St. Michael's Hospital

Toronto, Quebec, Canada

Site Status

CHRTR de Trois-Rivières

Trois-Rivières, Quebec, Canada

Site Status

CSSS Vallée de l'Or

Val-d'Or, Quebec, Canada

Site Status

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Related Links

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http://www.canadianimagingnetwork.org/

Canadian Atherosclerosis Imaging Network (CAIN) - "Hearts and Minds"

Other Identifiers

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CAIN-003

Identifier Type: -

Identifier Source: org_study_id

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