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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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

1339

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Nominal change at follow-up from baseline in percent atheroma volume (PAV) obtained using intravascular ultrasound (IVUS)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
plaque volume in target coronary artery
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
clinical endpoints
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Montreal Heart Institute

捜査官

  • 主任研究者：Jean-Claude Tardif, M.D、Montreal Heart Institute

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2010年2月3日

一次修了 (実際)

2017年12月12日

研究の完了 (実際)

2017年12月12日

試験登録日

最初に提出

2013年7月18日

QC基準を満たした最初の提出物

2014年4月13日

最初の投稿 (見積もり)

2014年4月15日

学習記録の更新

投稿された最後の更新 (実際)

2022年3月9日

QC基準を満たした最後の更新が送信されました

2022年2月22日

最終確認日

2022年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • CAIN-003_MHICC-31052012

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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