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Correlation Between Coronary and Carotid Atherosclerotic Disease and Links With Clinical Outcomes

2022년 2월 22일 업데이트: Montreal Heart Institute

Global Observational Study to Evaluate the Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes

The relationship of the natural history of atherosclerosis between different vascular beds has not been well characterized. Determination and comparison of the relative rates of progression and extents of atherosclerosis in the coronary and carotid arterial trees may have major impacts on clinical research and clinical practice. Correlation between findings in the carotid and coronary circulations is an important scientific and clinical topic to address. Results from a well design study incorporating imaging technologies that currently represent the gold standards for the assessment of coronary and carotid artery plaque burden, will have potentially impact on clinical research and clinical practice.

연구 개요

상태

완전한

정황

상세 설명

The CAIN-003 study was a prospective observational multi-center imaging study of subjects scheduled for clinically-indicated coronary angiography. CAIN-003 provided for the collection of baseline coronary angiography and IVUS imaging data along with baseline carotid ultrasound imaging. CAIN-003 study participants underwent follow-up coronary and carotid imaging at 2-years, and were then contacted by phone on an annual basis for an additional 3 years for the collection of cardiovascular and cerebrovascular clinical endpoints.

MHICC-31052012 was a prospective, observational, multi-center study of subjects who had successfully undergone baseline imaging in the dal-PLAQUE 2 study (A multicenter, double-blind, randomized, placebo-controlled study, evaluating the effect of treatment with dalcetrapib 600 mg on atherosclerosis disease). The dal-PLAQUE 2 study, which provided for the collection of baseline and 2-year follow-up coronary angiography, coronary IVUS and carotid ultrasound imaging data, was terminated by the sponsor prior to completion due to the discontinuation of the dalcetrapib drug development program. The MHICC-31052012 study allowed for the collection of follow-up imaging and clinical endpoint data from subjects who had successfully undergone baseline IVUS imaging in dal-PLAQUE 2.

Data from CAIN-003 and MHICC-31052012 was pooled to support the objective of determining the correlation and clinical relevance of these imaging endpoints.

The objectives of the CAIN-003 and MHICC-31052012 study were:

  • To compare the extent of atherosclerosis present in the coronary vasculature with the extent of atherosclerosis present in the carotid vasculature at a single point in time.
  • To compare the associations of atherosclerosis burden with coronary risk factors in the coronary arteries and carotid arteries, in multivariable regression.
  • To compare the rate of atherosclerosis progression or regression in the coronary vasculature with the rate of atherosclerosis progression or regression in the carotid vasculature over a 2-year period.
  • To determine the correlation between imaging biomarkers and cardiovascular outcomes over a 5-year period.

연구 유형

관찰

등록 (실제)

1339

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 독일
      • Aachen, 독일, 52074
        • Universitätsklinikum Aachen
      • Darmstadt, 독일, 64283
        • Klinikum Darmstadt
      • Heidelberg, 독일, 69120
        • Universitat Heidelberg
      • Ulm, 독일, 89081
        • Universitätsklinikum Ulm
  • 미국
    • California
      • Los Angeles, California, 미국, 90033
        • University of Southern California
      • Torrance, California, 미국, 90502
        • Los Angeles Biomedical Research Institute at Harbor
    • Florida
      • Fort Lauderdale, Florida, 미국, 33308
        • Jim Moran Heart and Vascular Research Institute, Holy Cross Hospital
      • Sarasota, Florida, 미국, 34239
        • Sarasota Memorial Hospital
      • Tampa, Florida, 미국, 33609
        • Florida Cardiovascular Research
    • Georgia
      • Decatur, Georgia, 미국, 30033
        • Emory University VA Medical Center
    • Kentucky
      • Louisville, Kentucky, 미국, 40205
        • Norton Heart Specialist Springs
    • Maryland
      • Columbia, Maryland, 미국, 21044-2991
        • John Hopkins University Office Capitol Region Research-CAPRES
    • Michigan
      • Midland, Michigan, 미국, 48670
        • CV Research at MidMichigan Medical Center Midland
      • Muskegon, Michigan, 미국, 49444
        • Mercy Health Partners
      • Petoskey, Michigan, 미국, 49770
        • Cardiac and Vascular Research Center of Northern Michigan
    • New Jersey
      • Ridgewood, New Jersey, 미국, 07450
        • The Valley Hospital
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27599
        • University of North Carolina Hospital
    • Ohio
      • Toledo, Ohio, 미국, 43614
        • University of Toledo Medical Center
    • Tennessee
      • Oak Ridge, Tennessee, 미국, 37830
        • Parkway Cardiology Associates
    • Texas
      • Dallas, Texas, 미국, 75216
        • Dalla VAMC
  • 스위스
      • Geneve, 스위스, 1211
        • Hôpitaux Universitaire de Genève
  • 캐나다
      • Calgary, 캐나다, T2N 2T9
        • Foothills Medical Centre
    • Alberta
      • Edmonton, Alberta, 캐나다, T5H 3V9
        • Royal Alexandra Hospital
      • Edmonton, Alberta, 캐나다, T6G 2B7
        • Mazankowski Alberta Heart Institute University Of Alberta Hospital ABACUS
    • British Columbia
      • New Westminster, British Columbia, 캐나다, V3L 3W4
        • Royal Columbian Hospital
      • Vancouver, British Columbia, 캐나다, V5Z 1M9
        • Vancouver General Hospital
      • Vancouver, British Columbia, 캐나다, V6E 1M7
        • Interventional Cardiology Research, St. Paul's Hospital
      • Victoria, British Columbia, 캐나다, V8R 4R2
        • Victoria Heart Institute Foundation (Office)/Royal Jubilee Hospital
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, 캐나다, A1B 3V6
        • Eastern Regional Health Authority
    • Nova Scotia
      • Halifax, Nova Scotia, 캐나다, B3H 3A7
        • Queen Elizabeth II - Health Sciences Centre
    • Ontario
      • Cambridge, Ontario, 캐나다, N1R 6V6
        • Cambridge Cardiac Care
      • Hamilton, Ontario, 캐나다, L8L 2X2
        • McMaster Clinic Hamilton General Hospital
      • Kitchener, Ontario, 캐나다, N2M 5N4
        • KMH Cardiology & Diagnostics Centre
      • London, Ontario, 캐나다, N6A 5A5
        • University Hospital/LHSC
      • Mississauga, Ontario, 캐나다, L5K 2L3
        • KMH Cardiology & Diagnostics Centre
      • Newmarket, Ontario, 캐나다, L3Y 2P7
        • York PCI Research
      • Oshawa, Ontario, 캐나다, L1J 2J9
        • Heart Care Research
      • Ottawa, Ontario, 캐나다, K1Y 4W7
        • Ottawa Civic Hospital / University of Ottawa Heart Institute
      • Scarborough, Ontario, 캐나다, M1E 5E9
        • Scarborough Cardiology Research
      • Toronto, Ontario, 캐나다, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, 캐나다, M5G 2C4
        • University Health Network
    • Quebec
      • Chicoutimi, Quebec, 캐나다, G7H 5H6
        • Complexe hospitalier de la Sagamie
      • Fleurimont, Quebec, 캐나다, J1H 5N4
        • CHUS-Hopital Fleurimont
      • Gatineau, Quebec, 캐나다, J8Y 1W7
        • CSSS-Hopital de Gatineau, secteur Hull
      • Gatineau, Quebec, 캐나다, J8Y 6S8
        • Q & T Research
      • Greenfield Park, Quebec, 캐나다, J4V 2G8
        • Viacar Recherche Clinique
      • Laval, Quebec, 캐나다, H7M 3L9
        • Cite de la Sante
      • Longueuil, Quebec, 캐나다, J4M 2X1
        • CDRC Rive Sud
      • Longueuil, Quebec, 캐나다, J4M 2X1
        • Foothills Medical Centre
      • Montréal, Quebec, 캐나다, H4J 1C5
        • Hopital Sacre-Coeur de Montreal
      • Montréal, Quebec, 캐나다, H1T 1N6
        • Montreal Heart Institute
      • Montréal, Quebec, 캐나다, H2W 1T8
        • CHUM - Hopital Hotel-Dieu
      • Montréal, Quebec, 캐나다, H3G 1A4
        • CUSM Montreal General Hospital
      • Québec, Quebec, 캐나다, G1V 4G5
        • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
      • Saint-Charles-Borromée, Quebec, 캐나다, J6E 6J2
        • Centre hospitalier régional de Lanaudière
      • Saint-Georges, Quebec, 캐나다, G5Y 4T8
        • Centre de santé et des services sociaux de Beauce
      • Saint-Jérôme, Quebec, 캐나다, J7Z 5T3
        • St-Jerome Medical Research Inc.
      • Toronto, Quebec, 캐나다, M4N 3M5
        • Sunnybrook Health Science Center
      • Trois-Rivières, Quebec, 캐나다, G9A 1Y1
        • Centre de santé et de services sociaux de Trois-Rivières
      • Val D'Or, Quebec, 캐나다, J9P 3Y1
        • CSSS Vallée de l'Or
    • Saskatchewan
      • Saskatoon, Saskatchewan, 캐나다, S7N OW8
        • Royal University Hospital
  • 폴란드
      • Elblag, 폴란드, 82-300
        • Wojewodzki Szpital
      • Gdansk, 폴란드, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, 폴란드, 31-202
        • Oddzial Kliniczny Choroby
      • Lublin, 폴란드, 20-954
        • Samodzielny Publiczny
      • Poznan, 폴란드, 61-848
        • Szpital Kliniczny
      • Warszawa, 폴란드, 02-507
        • Klinika Kardiologii
      • Warszawa, 폴란드, 4-628
        • Instytut Kardiologii
      • Wroclaw, 폴란드, 50-981
        • Woskowy Szpital Kliniczny

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Subjects who were scheduled for clinically-indicated coronary angiography and undergone baseline coronary angiography and IVUS imaging data along with baseline carotid ultrasound imaging.

설명

Inclusion Criteria:

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

  5. Angiographic inclusion criteria:

    • Entire Coronary Circulation: The patient must have angiographic evidence of coronary artery disease as defined by at least one lesion in any of the three major native coronary arteries that has >20% reduction in lumen diameter by angiographic visual estimation or prior history of PCI. This vessel does not need to be the target coronary artery for IVUS. Any vessel with previous PCI may not be used as the target coronary artery.
    • Left Main Coronary Artery: The patient must not have > 50% reduction in lumen diameter by visual angiographic estimation.
    • Target Coronary Artery: Patient will be required to have one "target" coronary artery for IVUS that has not undergone prior PCI, that is not a candidate to undergo PCI presently or in the next 24 months, and that has not been the cause of a recent myocardial infarction. The proximal 4 cm of the "target" artery in which

IVUS examination will be performed at baseline:

  • Must have a diameter stenosis < 50% lumen diameter by visual assessment of the angiogram;
  • Must have a reference diameter > 2.5 mm;
  • Must be free of filling defects suggestive of thrombus;
  • Must not present any anatomical characteristic (such as but not limited to severe tortuosity or calcification) that would impede IVUS interrogation at baseline or follow-up
  • Note: a lesion of up to 60% stenosis is permitted, distal to the target segment. A side branch of the target coronary artery for IVUS may not be a target for PCI.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

  1. 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.
  2. Previous coronary artery bypass graft (CABG) surgery or probable need for CABG in the next 24 months.
  3. Patients who have symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] Class III or IV) at baseline.
  4. Patients with clinically significant valvular heart disease likely to require surgical repair or replacement during the treatment period of the study
  5. 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.
  6. The presence of severe liver disease as defined by the presence of cirrhosis, chronic active hepatitis, or chronic jaundice with hyperbilirubinemia,
  7. Patients with eGFR < 45 ml/min prior to baseline imaging procedures, or with nephrotic syndrome
  8. Patients with a life expectancy less than 2 years.
  9. History of malignancy (except for curatively treated basal cell or squamous cell carcinoma of the skin) during the 3 years prior to the screening.
  10. Unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Nominal change at follow-up from baseline in percent atheroma volume (PAV) obtained using intravascular ultrasound (IVUS)
기간: Participants will have a baseline IVUS and a two year follow-up IVUS
This endpoint will be the nominal change at follow-up from baseline in percent atheroma volume computed by dividing plaque volume by external elastic membrane volume and then multiplying by 100 at both time points, baseline and 2 year follow-up.
Participants will have a baseline IVUS and a two year follow-up IVUS

2차 결과 측정

결과 측정
측정값 설명
기간
plaque volume in target coronary artery
기간: change at 2 year follow-up from baseline
This secondary IVUS endpoint will include the nominal change in plaque volume in the target coronary artery, as well as the percent (relative) change in plaque volume.
change at 2 year follow-up from baseline
change in plaque volume in the 5-mm sub-segment of target coronary artery
기간: change at 2 year follow-up from baseline
change in plaque volume in the 5-mm sub-segment with the greatest disease burden at baseline, and change in plaque volume in the 5-mm sub-segment with the smallest plaque area at baseline.
change at 2 year follow-up from baseline
Total vessel volume in the target coronary artery
기간: change at final 2 year follow-up from baseline
Total vessel volume for all anatomically comparable slices in the 30-mm target coronary artery segment and the change in plaque characterization indices.
change at final 2 year follow-up from baseline
change in coronary score assessed by quantitative coronary angiography
기간: change at final 2 year follow-up from baseline
Evaluation of change in coronary score assessed by quantitative coronary angiography and defined as the per-patient mean of the minimal lumen diameter for all lesions measured. As well evaluation of the cumulative coronary stenosis score (calculated by adding all percent diameter stenoses in standard international units).
change at final 2 year follow-up from baseline
nominal change in carotid IMT(CIMT)
기간: change at final 2 year follow-up from baseline
This secondary endpoint will be obtained using 2D B-mode carotid ultrasound and will be the nominal change at final follow-up from baseline in carotid IMT(CIMT), where CIMT is computed as the per scan average of the mean IMT values of carotid segments.
change at final 2 year follow-up from baseline

기타 결과 측정

결과 측정
측정값 설명
기간
clinical endpoints
기간: up to five year follow-up
Clinical endpoints: death, coronary heart disease, resuscitated cardiac arrest, non-fatal myocardial infarction, stroke, hospitalization for documented acute coronary syndrome (ECG abnormalities without biomarkers), coronary revascularization procedure and carotid artery surgery or angioplasty.
up to five year follow-up

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Montreal Heart Institute

수사관

  • 수석 연구원: Jean-Claude Tardif, M.D, Montreal Heart Institute

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2010년 2월 3일

기본 완료 (실제)

2017년 12월 12일

연구 완료 (실제)

2017년 12월 12일

연구 등록 날짜

최초 제출

2013년 7월 18일

QC 기준을 충족하는 최초 제출

2014년 4월 13일

처음 게시됨 (추정)

2014년 4월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 3월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 2월 22일

마지막으로 확인됨

2022년 2월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CAIN-003_MHICC-31052012

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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