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

2022年2月22日 更新者：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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

观察性的

注册 (实际的)

1339

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Nominal change at follow-up from baseline in percent atheroma volume (PAV) obtained using intravascular ultrasound (IVUS)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
plaque volume in target coronary artery
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
clinical endpoints
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Montreal Heart Institute

调查人员

  • 首席研究员：Jean-Claude Tardif, M.D、Montreal Heart Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年2月3日

初级完成 (实际的)

2017年12月12日

研究完成 (实际的)

2017年12月12日

研究注册日期

首次提交

2013年7月18日

首先提交符合 QC 标准的

2014年4月13日

首次发布 (估计)

2014年4月15日

研究记录更新

最后更新发布 (实际的)

2022年3月9日

上次提交的符合 QC 标准的更新

2022年2月22日

最后验证

2022年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CAIN-003_MHICC-31052012

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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