Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
20 februari 2020 uppdaterad av: Canadian Atherosclerosis Imaging Network
This is a prospective, multi-center imaging study expecting to enroll approximately 1350 patients scheduled for clinically-indicated coronary angiography. Following informed consent, patient will undergo baseline coronary intravascular ultrasound (IVUS) imaging and non-invasive ultrasound imaging of their carotid arteries. Following a 2-year follow-up period, patients will undergo repeat coronary IVUS and standard invasive coronary angiography as well as carotid ultrasound examination.
Additionally, patients will be contacted by phone on an annual basis for 5 years to collect cardiovascular and cerebrovascular clinical endpoints. Evaluations of plaque burden will be made using invasive and non invasive imaging tools in order to assess correlations between vascular beds, imaging technologies and main cardiovascular events.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
CTA and PET Substudy:
A subset of patients enrolled into the main CAIN3 study will undergo a CTA. At sites where both CTA and PET imaging modalities exist, patients will be asked to undergo both tests. The CTA and PET scans can be done separately on 2 imaging beds on different days or performed on the same imaging bed, resulting in a combined CTA and PET scan being done in one scheduled visit. All imaging will be done within 90 days after the follow up IVUS.
The choice of radiotracer used (NaF or FDG) for PET imaging will be dependent upon site and availability on the day of the scan. A total of 120 patients will be enrolled in this substudy with approximately 50-60 undergoing CTA and PET.
Studietyp
Observationell
Inskrivning (Faktisk)
1626
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Quebec, Kanada, G1V 4G5
- Institut Universitaire De Cardiologie Et De Pneumologie De Québec
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Alberta
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Edmonton, Alberta, Kanada, T5H 3V9
- Royal Alexandra Hospital
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Edmonton, Alberta, Kanada, T6L 5X8
- University of Alberta Hospital
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British Columbia
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Calgary, British Columbia, Kanada, T2N 2T9
- Foothills Medical Centre
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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, V6Z 1Y6
- Interventional Cardiology Research, St. Paul's Hospital
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Victoria, British Columbia, Kanada, V8R 4R2
- Victoria Heart Institute Foundation
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Newfoundland and Labrador
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St John's, Newfoundland and Labrador, Kanada, A1B 3V6
- John Health Science Center
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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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Kitchener, Ontario, Kanada, N2M 1B2
- St-Mary's Hospital
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London, Ontario, Kanada, N6G 2V2
- London Health Sciences Center
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Mississauga, Ontario, Kanada, L5K 2L3
- KMH Cardiology & Diagnostics Centre
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Newmarket, Ontario, Kanada, L3Y 2R2
- Southlake Regional Health Center
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Oshawa, Ontario, Kanada, L1J 2J9
- Heart Care Research
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Ottawa, Ontario, Kanada, K1Y 4W7
- University of Ottawa Heart Institute
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Scarborough, Ontario, Kanada, M1E 5E9
- Scarborough Cardiology Research
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Toronto, Ontario, Kanada, M5G 2C4
- University Health Network
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Toronto, Ontario, Kanada, M4N 3M5
- Sunnybrook Health Science Center
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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 6S9
- CSSS-Hopital de Gatineau, secteur Hull
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Greenfield Park, Quebec, Kanada, J4V 2G8
- Viacar Recherche Clinique
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Laval, Quebec, Kanada, H7M 3L9
- CSSS de Laval
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Longueuil, Quebec, Kanada, J4M 2X1
- Hopital Pierre Boucher
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Montreal, Quebec, Kanada, H1T 1C8
- Montreal Heart Institute
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Montreal, Quebec, Kanada, H4J 1C5
- Hôpital Sacré-Coeur de Montréal
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Montreal, Quebec, Kanada, H2W 1T8
- CHUM Hopital-Hôtel-Dieu
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Montreal, Quebec, Kanada, H3G 1A4
- CUSM Montreal General Hospital
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Saint-Georges, Quebec, Kanada, G5Y 4T8
- Centre de santé et des services sociaux de Beauce
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St-Charles-Borromée, Quebec, Kanada, J6E 6J2
- Centre Hospitalier Régional de Lanaudière
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St-Jerome, Quebec, Kanada, J7Z 5T3
- St-Jerome Medical Research Inc.
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Toronto, Quebec, Kanada, M5B 1W8
- St. Michael's Hospital
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Trois-Rivières, Quebec, Kanada, G8Z 3R9
- CHRTR 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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients with clinical indication for coronary angiography
Beskrivning
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.
- Angiogram meeting qualifying criteria
Exclusion Criteria:
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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co-primary outcome measure - Nominal change from baseline in percent atheroma volume
Tidsram: 2 years
|
intravascular ultrasound measure
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2 years
|
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co-primary outcome measure - nominal change from baseline in carotid IMT
Tidsram: 2 years
|
2D B-mode carotid ultrasound measure
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2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
cardiovascular morbidity and mortality
Tidsram: 5 years
|
as adjudicated by a Clinical Endpoint Committee
|
5 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Studiestol: Jean-Claude Tardif, MD, Montreal Heart Institute
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2010
Primärt slutförande (Faktisk)
1 december 2017
Avslutad studie (Faktisk)
1 december 2017
Studieregistreringsdatum
Först inskickad
12 maj 2011
Först inskickad som uppfyllde QC-kriterierna
12 maj 2011
Första postat (Uppskatta)
13 maj 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 februari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 februari 2020
Senast verifierad
1 februari 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CAIN-003
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .