Correlation Between Coronary and Carotid Atherosclerotic Disease and Links With Clinical Outcomes
22 февраля 2022 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Подробное описание
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.
Тип исследования
Наблюдательный
Регистрация (Действительный)
1339
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Aachen, Германия, 52074
- Universitätsklinikum Aachen
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Darmstadt, Германия, 64283
- Klinikum Darmstadt
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Heidelberg, Германия, 69120
- Universitat Heidelberg
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Ulm, Германия, 89081
- Universitatsklinikum Ulm
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Calgary, Канада, T2N 2T9
- Foothills Medical Centre
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Alberta
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Edmonton, Alberta, Канада, T5H 3V9
- Royal Alexandra Hospital
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Edmonton, Alberta, Канада, T6G 2B7
- Mazankowski Alberta Heart Institute University Of Alberta Hospital ABACUS
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British Columbia
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New Westminster, British Columbia, Канада, V3L 3W4
- Royal Columbian Hospital
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Vancouver, British Columbia, Канада, V5Z 1M9
- Vancouver General Hospital
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Vancouver, British Columbia, Канада, V6E 1M7
- Interventional Cardiology Research, St. Paul's Hospital
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Victoria, British Columbia, Канада, V8R 4R2
- Victoria Heart Institute Foundation (Office)/Royal Jubilee Hospital
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Newfoundland and Labrador
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Saint John's, Newfoundland and Labrador, Канада, A1B 3V6
- Eastern Regional Health Authority
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Nova Scotia
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Halifax, Nova Scotia, Канада, B3H 3A7
- Queen Elizabeth II - Health Sciences Centre
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Ontario
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Cambridge, Ontario, Канада, N1R 6V6
- Cambridge Cardiac Care
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Hamilton, Ontario, Канада, L8L 2X2
- McMaster Clinic Hamilton General Hospital
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Kitchener, Ontario, Канада, N2M 5N4
- KMH Cardiology & Diagnostics Centre
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London, Ontario, Канада, N6A 5A5
- University Hospital/LHSC
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Mississauga, Ontario, Канада, L5K 2L3
- KMH Cardiology & Diagnostics Centre
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Newmarket, Ontario, Канада, L3Y 2P7
- York PCI Research
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Oshawa, Ontario, Канада, L1J 2J9
- Heart Care Research
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Ottawa, Ontario, Канада, K1Y 4W7
- Ottawa Civic Hospital / University of Ottawa Heart Institute
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Scarborough, Ontario, Канада, M1E 5E9
- Scarborough Cardiology Research
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Toronto, Ontario, Канада, M5B 1W8
- St. Michael's Hospital
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Toronto, Ontario, Канада, M5G 2C4
- University Health Network
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Quebec
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Chicoutimi, Quebec, Канада, G7H 5H6
- Complexe Hospitalier de la Sagamie
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Fleurimont, Quebec, Канада, J1H 5N4
- CHUS-Hopital Fleurimont
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Gatineau, Quebec, Канада, J8Y 1W7
- CSSS-Hopital de Gatineau, secteur Hull
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Gatineau, Quebec, Канада, J8Y 6S8
- Q & T Research
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Greenfield Park, Quebec, Канада, J4V 2G8
- Viacar Recherche Clinique
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Laval, Quebec, Канада, H7M 3L9
- Cite de la Sante
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Longueuil, Quebec, Канада, J4M 2X1
- CDRC Rive Sud
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Longueuil, Quebec, Канада, J4M 2X1
- Foothills Medical Centre
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Montréal, Quebec, Канада, H4J 1C5
- Hopital Sacre-Coeur de Montreal
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Montréal, Quebec, Канада, H1T 1N6
- Montreal Heart Institute
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Montréal, Quebec, Канада, H2W 1T8
- CHUM - Hopital Hotel-Dieu
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Montréal, Quebec, Канада, H3G 1A4
- CUSM Montreal General Hospital
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Québec, Quebec, Канада, G1V 4G5
- Institut Universitaire De Cardiologie Et De Pneumologie De Québec
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Saint-Charles-Borromée, Quebec, Канада, J6E 6J2
- Centre Hospitalier Régional de Lanaudière
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Saint-Georges, Quebec, Канада, G5Y 4T8
- Centre de santé et des services sociaux de Beauce
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Saint-Jérôme, Quebec, Канада, J7Z 5T3
- St-Jerome Medical Research Inc.
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Toronto, Quebec, Канада, M4N 3M5
- Sunnybrook Health Science Center
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Trois-Rivières, Quebec, Канада, G9A 1Y1
- Centre de santé et de services sociaux de Trois-Rivières
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Val D'Or, Quebec, Канада, J9P 3Y1
- CSSS Vallée de l'Or
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Saskatchewan
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Saskatoon, Saskatchewan, Канада, S7N OW8
- Royal University Hospital
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Elblag, Польша, 82-300
- Wojewodzki Szpital
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Gdansk, Польша, 80-952
- Uniwersyteckie Centrum Kliniczne
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Krakow, Польша, 31-202
- Oddzial Kliniczny Choroby
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Lublin, Польша, 20-954
- Samodzielny Publiczny
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Poznan, Польша, 61-848
- Szpital Kliniczny
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Warszawa, Польша, 02-507
- Klinika Kardiologii
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Warszawa, Польша, 4-628
- Instytut Kardiologii
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Wroclaw, Польша, 50-981
- Woskowy Szpital Kliniczny
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California
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Los Angeles, California, Соединенные Штаты, 90033
- University of Southern California
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Torrance, California, Соединенные Штаты, 90502
- Los Angeles Biomedical Research Institute at Harbor
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Florida
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Fort Lauderdale, Florida, Соединенные Штаты, 33308
- Jim Moran Heart and Vascular Research Institute, Holy Cross Hospital
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Sarasota, Florida, Соединенные Штаты, 34239
- Sarasota Memorial Hospital
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Tampa, Florida, Соединенные Штаты, 33609
- Florida Cardiovascular Research
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Georgia
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Decatur, Georgia, Соединенные Штаты, 30033
- Emory University VA Medical Center
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Kentucky
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Louisville, Kentucky, Соединенные Штаты, 40205
- Norton Heart Specialist Springs
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Maryland
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Columbia, Maryland, Соединенные Штаты, 21044-2991
- John Hopkins University Office Capitol Region Research-CAPRES
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Michigan
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Midland, Michigan, Соединенные Штаты, 48670
- CV Research at MidMichigan Medical Center Midland
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Muskegon, Michigan, Соединенные Штаты, 49444
- Mercy Health Partners
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Petoskey, Michigan, Соединенные Штаты, 49770
- Cardiac and Vascular Research Center of Northern Michigan
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New Jersey
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Ridgewood, New Jersey, Соединенные Штаты, 07450
- The Valley Hospital
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North Carolina
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Chapel Hill, North Carolina, Соединенные Штаты, 27599
- University of North Carolina Hospital
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Ohio
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Toledo, Ohio, Соединенные Штаты, 43614
- University of Toledo Medical Center
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Tennessee
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Oak Ridge, Tennessee, Соединенные Штаты, 37830
- Parkway Cardiology Associates
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Texas
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Dallas, Texas, Соединенные Штаты, 75216
- Dalla VAMC
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Geneve, Швейцария, 1211
- Hôpitaux Universitaire de Genève
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Метод выборки
Невероятностная выборка
Исследуемая популяция
Subjects who were scheduled for clinically-indicated coronary angiography and undergone baseline coronary angiography and IVUS imaging data along with baseline carotid ultrasound imaging.
Описание
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.
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:
- 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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Nominal change at follow-up from baseline in percent atheroma volume (PAV) obtained using intravascular ultrasound (IVUS)
Временное ограничение: Participants will have a baseline IVUS and a two year follow-up IVUS
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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.
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Participants will have a baseline IVUS and a two year follow-up IVUS
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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plaque volume in target coronary artery
Временное ограничение: change at 2 year follow-up from baseline
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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.
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change at 2 year follow-up from baseline
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change in plaque volume in the 5-mm sub-segment of target coronary artery
Временное ограничение: change at 2 year follow-up from baseline
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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.
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change at 2 year follow-up from baseline
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Total vessel volume in the target coronary artery
Временное ограничение: change at final 2 year follow-up from baseline
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Total vessel volume for all anatomically comparable slices in the 30-mm target coronary artery segment and the change in plaque characterization indices.
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change at final 2 year follow-up from baseline
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change in coronary score assessed by quantitative coronary angiography
Временное ограничение: change at final 2 year follow-up from baseline
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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).
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change at final 2 year follow-up from baseline
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nominal change in carotid IMT(CIMT)
Временное ограничение: change at final 2 year follow-up from baseline
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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.
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change at final 2 year follow-up from baseline
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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clinical endpoints
Временное ограничение: up to five year follow-up
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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.
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up to five year follow-up
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Jean-Claude Tardif, M.D, Montreal Heart Institute
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
3 февраля 2010 г.
Первичное завершение (Действительный)
12 декабря 2017 г.
Завершение исследования (Действительный)
12 декабря 2017 г.
Даты регистрации исследования
Первый отправленный
18 июля 2013 г.
Впервые представлено, что соответствует критериям контроля качества
13 апреля 2014 г.
Первый опубликованный (Оценивать)
15 апреля 2014 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
9 марта 2022 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
22 февраля 2022 г.
Последняя проверка
1 февраля 2022 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CAIN-003_MHICC-31052012
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .