Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
20. februar 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1626
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Quebec, Canada, G1V 4G5
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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Alberta
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Edmonton, Alberta, Canada, T5H 3V9
- Royal Alexandra Hospital
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Edmonton, Alberta, Canada, T6L 5X8
- University of Alberta Hospital
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British Columbia
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Calgary, British Columbia, Canada, T2N 2T9
- Foothills Medical Centre
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New Westminster, British Columbia, Canada, V3L 3W4
- Royal Columbian Hospital
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
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Vancouver, British Columbia, Canada, V6Z 1Y6
- Interventional Cardiology Research, St. Paul's Hospital
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Victoria, British Columbia, Canada, V8R 4R2
- Victoria Heart Institute Foundation
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Newfoundland and Labrador
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St John's, Newfoundland and Labrador, Canada, A1B 3V6
- John Health Science Center
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
- Queen Elizabeth II - Health Sciences Centre
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Ontario
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Cambridge, Ontario, Canada, N1R 6V6
- Cambridge Cardiac Care
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Hamilton, Ontario, Canada, L8L 2X2
- McMaster Clinic Hamilton General Hospital
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Kitchener, Ontario, Canada, N2M 5N4
- KMH Cardiology & Diagnostics Centre
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Kitchener, Ontario, Canada, N2M 1B2
- St-Mary's Hospital
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London, Ontario, Canada, N6G 2V2
- London Health Sciences Center
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Mississauga, Ontario, Canada, L5K 2L3
- KMH Cardiology & Diagnostics Centre
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Newmarket, Ontario, Canada, L3Y 2R2
- Southlake Regional Health Center
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Oshawa, Ontario, Canada, L1J 2J9
- Heart Care Research
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Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Institute
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Scarborough, Ontario, Canada, M1E 5E9
- Scarborough Cardiology Research
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Toronto, Ontario, Canada, M5G 2C4
- University Health Network
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Science Center
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
- Complexe Hospitalier de la Sagamie
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Fleurimont, Quebec, Canada, J1H 5N4
- CHUS-Hopital Fleurimont
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Gatineau, Quebec, Canada, J8Y 6S9
- CSSS-Hopital de Gatineau, secteur Hull
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Greenfield Park, Quebec, Canada, J4V 2G8
- Viacar Recherche Clinique
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Laval, Quebec, Canada, H7M 3L9
- CSSS de Laval
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Longueuil, Quebec, Canada, J4M 2X1
- Hopital Pierre Boucher
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Montreal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute
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Montreal, Quebec, Canada, H4J 1C5
- Hôpital Sacré-Coeur de Montréal
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Montreal, Quebec, Canada, H2W 1T8
- CHUM Hopital-Hôtel-Dieu
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Montreal, Quebec, Canada, H3G 1A4
- CUSM Montreal General Hospital
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Saint-Georges, Quebec, Canada, G5Y 4T8
- Centre de santé et des services sociaux de Beauce
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St-Charles-Borromée, Quebec, Canada, J6E 6J2
- Centre Hospitalier Régional de Lanaudière
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St-Jerome, Quebec, Canada, J7Z 5T3
- St-Jerome Medical Research Inc.
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Toronto, Quebec, Canada, M5B 1W8
- St. Michael's Hospital
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Trois-Rivières, Quebec, Canada, G8Z 3R9
- CHRTR de Trois-Rivières
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Val D'Or, Quebec, Canada, J9P 3Y1
- CSSS Vallée de l'Or
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N OW8
- Royal University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with clinical indication for coronary angiography
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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co-primary outcome measure - Nominal change from baseline in percent atheroma volume
Tidsramme: 2 years
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intravascular ultrasound measure
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2 years
|
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co-primary outcome measure - nominal change from baseline in carotid IMT
Tidsramme: 2 years
|
2D B-mode carotid ultrasound measure
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2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
cardiovascular morbidity and mortality
Tidsramme: 5 years
|
as adjudicated by a Clinical Endpoint Committee
|
5 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Jean-Claude Tardif, MD, Montreal Heart Institute
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2010
Primær færdiggørelse (Faktiske)
1. december 2017
Studieafslutning (Faktiske)
1. december 2017
Datoer for studieregistrering
Først indsendt
12. maj 2011
Først indsendt, der opfyldte QC-kriterier
12. maj 2011
Først opslået (Skøn)
13. maj 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. februar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. februar 2020
Sidst verificeret
1. februar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CAIN-003
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .