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

22 lutego 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

1339

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Nominal change at follow-up from baseline in percent atheroma volume (PAV) obtained using intravascular ultrasound (IVUS)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
plaque volume in target coronary artery
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
clinical endpoints
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Montreal Heart Institute

Śledczy

  • Główny śledczy: Jean-Claude Tardif, M.D, Montreal Heart Institute

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

3 lutego 2010

Zakończenie podstawowe (Rzeczywisty)

12 grudnia 2017

Ukończenie studiów (Rzeczywisty)

12 grudnia 2017

Daty rejestracji na studia

Pierwszy przesłany

18 lipca 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 kwietnia 2014

Pierwszy wysłany (Oszacować)

15 kwietnia 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 marca 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 lutego 2022

Ostatnia weryfikacja

1 lutego 2022

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CAIN-003_MHICC-31052012

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

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