Correlation Between Coronary and Carotid Atherosclerotic Disease and Links With Clinical Outcomes
2022. február 22. frissítette: 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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Részletes leírás
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.
Tanulmány típusa
Megfigyelő
Beiratkozás (Tényleges)
1339
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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California
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Los Angeles, California, Egyesült Államok, 90033
- University of Southern California
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Torrance, California, Egyesült Államok, 90502
- Los Angeles Biomedical Research Institute at Harbor
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Florida
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Fort Lauderdale, Florida, Egyesült Államok, 33308
- Jim Moran Heart and Vascular Research Institute, Holy Cross Hospital
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Sarasota, Florida, Egyesült Államok, 34239
- Sarasota Memorial Hospital
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Tampa, Florida, Egyesült Államok, 33609
- Florida Cardiovascular Research
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Georgia
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Decatur, Georgia, Egyesült Államok, 30033
- Emory University VA Medical Center
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Kentucky
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Louisville, Kentucky, Egyesült Államok, 40205
- Norton Heart Specialist Springs
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Maryland
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Columbia, Maryland, Egyesült Államok, 21044-2991
- John Hopkins University Office Capitol Region Research-CAPRES
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Michigan
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Midland, Michigan, Egyesült Államok, 48670
- CV Research at MidMichigan Medical Center Midland
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Muskegon, Michigan, Egyesült Államok, 49444
- Mercy Health Partners
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Petoskey, Michigan, Egyesült Államok, 49770
- Cardiac and Vascular Research Center of Northern Michigan
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New Jersey
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Ridgewood, New Jersey, Egyesült Államok, 07450
- The Valley Hospital
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North Carolina
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Chapel Hill, North Carolina, Egyesült Államok, 27599
- University of North Carolina Hospital
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Ohio
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Toledo, Ohio, Egyesült Államok, 43614
- University of Toledo Medical Center
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Tennessee
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Oak Ridge, Tennessee, Egyesült Államok, 37830
- Parkway Cardiology Associates
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Texas
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Dallas, Texas, Egyesült Államok, 75216
- Dalla VAMC
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Calgary, Kanada, T2N 2T9
- Foothills Medical Centre
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Alberta
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Edmonton, Alberta, Kanada, T5H 3V9
- Royal Alexandra Hospital
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Edmonton, Alberta, Kanada, 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, Kanada, V3L 3W4
- Royal Columbian Hospital
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Vancouver, British Columbia, Kanada, V5Z 1M9
- Vancouver General Hospital
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Vancouver, British Columbia, Kanada, V6E 1M7
- Interventional Cardiology Research, St. Paul's Hospital
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Victoria, British Columbia, Kanada, 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, Kanada, A1B 3V6
- Eastern Regional Health Authority
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 3A7
- Queen Elizabeth II - Health Sciences Centre
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Ontario
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Cambridge, Ontario, Kanada, N1R 6V6
- Cambridge Cardiac Care
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Hamilton, Ontario, Kanada, L8L 2X2
- McMaster Clinic Hamilton General Hospital
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Kitchener, Ontario, Kanada, N2M 5N4
- KMH Cardiology & Diagnostics Centre
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London, Ontario, Kanada, N6A 5A5
- University Hospital/LHSC
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Mississauga, Ontario, Kanada, L5K 2L3
- KMH Cardiology & Diagnostics Centre
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Newmarket, Ontario, Kanada, L3Y 2P7
- York PCI Research
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Oshawa, Ontario, Kanada, L1J 2J9
- Heart Care Research
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Ottawa, Ontario, Kanada, K1Y 4W7
- Ottawa Civic Hospital / University of Ottawa Heart Institute
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Scarborough, Ontario, Kanada, M1E 5E9
- Scarborough Cardiology Research
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Toronto, Ontario, Kanada, M5B 1W8
- St. Michael's Hospital
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Toronto, Ontario, Kanada, M5G 2C4
- University Health Network
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Quebec
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Chicoutimi, Quebec, Kanada, G7H 5H6
- Complexe Hospitalier de la Sagamie
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Fleurimont, Quebec, Kanada, J1H 5N4
- CHUS-Hopital Fleurimont
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Gatineau, Quebec, Kanada, J8Y 1W7
- CSSS-Hopital de Gatineau, secteur Hull
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Gatineau, Quebec, Kanada, J8Y 6S8
- Q & T Research
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Greenfield Park, Quebec, Kanada, J4V 2G8
- Viacar Recherche Clinique
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Laval, Quebec, Kanada, H7M 3L9
- Cite de la Sante
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Longueuil, Quebec, Kanada, J4M 2X1
- CDRC Rive Sud
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Longueuil, Quebec, Kanada, J4M 2X1
- Foothills Medical Centre
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Montréal, Quebec, Kanada, H4J 1C5
- Hôpital Sacré-Coeur de Montréal
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Montréal, Quebec, Kanada, H1T 1N6
- Montreal Heart Institute
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Montréal, Quebec, Kanada, H2W 1T8
- CHUM - Hopital Hotel-Dieu
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Montréal, Quebec, Kanada, H3G 1A4
- CUSM Montreal General Hospital
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Québec, Quebec, Kanada, G1V 4G5
- Institut Universitaire De Cardiologie Et De Pneumologie De Québec
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Saint-Charles-Borromée, Quebec, Kanada, J6E 6J2
- Centre Hospitalier Régional de Lanaudière
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Saint-Georges, Quebec, Kanada, G5Y 4T8
- Centre de santé et des services sociaux de Beauce
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Saint-Jérôme, Quebec, Kanada, J7Z 5T3
- St-Jerome Medical Research Inc.
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Toronto, Quebec, Kanada, M4N 3M5
- Sunnybrook Health Science Center
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Trois-Rivières, Quebec, Kanada, G9A 1Y1
- Centre de santé et de services sociaux de Trois-Rivières
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Val D'Or, Quebec, Kanada, J9P 3Y1
- CSSS Vallée de l'Or
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7N OW8
- Royal University Hospital
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Elblag, Lengyelország, 82-300
- Wojewodzki Szpital
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Gdansk, Lengyelország, 80-952
- Uniwersyteckie Centrum Kliniczne
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Krakow, Lengyelország, 31-202
- Oddzial Kliniczny Choroby
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Lublin, Lengyelország, 20-954
- Samodzielny Publiczny
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Poznan, Lengyelország, 61-848
- Szpital Kliniczny
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Warszawa, Lengyelország, 02-507
- Klinika Kardiologii
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Warszawa, Lengyelország, 4-628
- Instytut Kardiologii
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Wroclaw, Lengyelország, 50-981
- Woskowy Szpital Kliniczny
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Aachen, Németország, 52074
- Universitätsklinikum Aachen
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Darmstadt, Németország, 64283
- Klinikum Darmstadt
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Heidelberg, Németország, 69120
- Universität Heidelberg
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Ulm, Németország, 89081
- Universitätsklinikum Ulm
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Geneve, Svájc, 1211
- Hôpitaux Universitaire de Genève
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Igen
Tanulmányozható nemek
Összes
Mintavételi módszer
Nem valószínűségi minta
Tanulmányi populáció
Subjects who were scheduled for clinically-indicated coronary angiography and undergone baseline coronary angiography and IVUS imaging data along with baseline carotid ultrasound imaging.
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Nominal change at follow-up from baseline in percent atheroma volume (PAV) obtained using intravascular ultrasound (IVUS)
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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plaque volume in target coronary artery
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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clinical endpoints
Időkeret: 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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: Jean-Claude Tardif, M.D, Montreal Heart Institute
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2010. február 3.
Elsődleges befejezés (Tényleges)
2017. december 12.
A tanulmány befejezése (Tényleges)
2017. december 12.
Tanulmányi regisztráció dátumai
Először benyújtva
2013. július 18.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2014. április 13.
Első közzététel (Becslés)
2014. április 15.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2022. március 9.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2022. február 22.
Utolsó ellenőrzés
2022. február 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- CAIN-003_MHICC-31052012
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
ELDÖNTETLEN
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
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