Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Quebec, 캐나다, G1V 4G5
- Institut Universitaire de cardiologie et de pneumologie de Quebec
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Alberta
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Edmonton, Alberta, 캐나다, T5H 3V9
- Royal Alexandra Hospital
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Edmonton, Alberta, 캐나다, T6L 5X8
- University of Alberta Hospital
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British Columbia
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Calgary, British Columbia, 캐나다, T2N 2T9
- Foothills Medical Centre
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New Westminster, British Columbia, 캐나다, V3L 3W4
- Royal Columbian Hospital
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Vancouver, British Columbia, 캐나다, V5Z 1M9
- Vancouver General Hospital
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Vancouver, British Columbia, 캐나다, V6Z 1Y6
- Interventional Cardiology Research, St. Paul's Hospital
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Victoria, British Columbia, 캐나다, V8R 4R2
- Victoria Heart Institute Foundation
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Newfoundland and Labrador
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St John's, Newfoundland and Labrador, 캐나다, A1B 3V6
- John Health Science Center
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 3A7
- Queen Elizabeth II - Health Sciences Centre
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Ontario
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Cambridge, Ontario, 캐나다, N1R 6V6
- Cambridge Cardiac Care
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Hamilton, Ontario, 캐나다, L8L 2X2
- McMaster Clinic Hamilton General Hospital
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Kitchener, Ontario, 캐나다, N2M 5N4
- KMH Cardiology & Diagnostics Centre
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Kitchener, Ontario, 캐나다, N2M 1B2
- St-Mary's Hospital
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London, Ontario, 캐나다, N6G 2V2
- London Health Sciences Center
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Mississauga, Ontario, 캐나다, L5K 2L3
- KMH Cardiology & Diagnostics Centre
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Newmarket, Ontario, 캐나다, L3Y 2R2
- Southlake Regional Health Center
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Oshawa, Ontario, 캐나다, L1J 2J9
- Heart Care Research
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Ottawa, Ontario, 캐나다, K1Y 4W7
- University of Ottawa Heart Institute
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Scarborough, Ontario, 캐나다, M1E 5E9
- Scarborough Cardiology Research
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Toronto, Ontario, 캐나다, M5G 2C4
- University Health Network
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Toronto, Ontario, 캐나다, M4N 3M5
- Sunnybrook Health Science Center
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Quebec
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Chicoutimi, Quebec, 캐나다, G7H 5H6
- Complexe hospitalier de la Sagamie
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Fleurimont, Quebec, 캐나다, J1H 5N4
- CHUS-Hopital Fleurimont
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Gatineau, Quebec, 캐나다, J8Y 6S9
- CSSS-Hopital de Gatineau, secteur Hull
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Greenfield Park, Quebec, 캐나다, J4V 2G8
- Viacar Recherche Clinique
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Laval, Quebec, 캐나다, H7M 3L9
- CSSS de Laval
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Longueuil, Quebec, 캐나다, J4M 2X1
- Hôpital Pierre Boucher
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Montreal, Quebec, 캐나다, H1T 1C8
- Montreal Heart Institute
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Montreal, Quebec, 캐나다, H4J 1C5
- Hôpital Sacré-Coeur de Montréal
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Montreal, Quebec, 캐나다, H2W 1T8
- CHUM Hopital-Hôtel-Dieu
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Montreal, Quebec, 캐나다, H3G 1A4
- CUSM Montreal General Hospital
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Saint-Georges, Quebec, 캐나다, G5Y 4T8
- Centre de santé et des services sociaux de Beauce
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St-Charles-Borromée, Quebec, 캐나다, J6E 6J2
- Centre hospitalier régional de Lanaudière
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St-Jerome, Quebec, 캐나다, J7Z 5T3
- St-Jerome Medical Research Inc.
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Toronto, Quebec, 캐나다, M5B 1W8
- St. Michael's Hospital
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Trois-Rivières, Quebec, 캐나다, G8Z 3R9
- CHRTR de Trois-Rivières
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Val D'Or, Quebec, 캐나다, J9P 3Y1
- CSSS Vallée de l'Or
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Saskatchewan
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Saskatoon, Saskatchewan, 캐나다, S7N OW8
- Royal University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
co-primary outcome measure - Nominal change from baseline in percent atheroma volume
기간: 2 years
|
intravascular ultrasound measure
|
2 years
|
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co-primary outcome measure - nominal change from baseline in carotid IMT
기간: 2 years
|
2D B-mode carotid ultrasound measure
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2 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
cardiovascular morbidity and mortality
기간: 5 years
|
as adjudicated by a Clinical Endpoint Committee
|
5 years
|
공동 작업자 및 조사자
수사관
- 연구 의자: Jean-Claude Tardif, MD, Montreal Heart Institute
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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