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Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes

20 de fevereiro de 2020 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Aterosclerose

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

1626

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Canadá
- - Quebec, Canadá, G1V 4G5
    - Institut Universitaire de cardiologie et de pneumologie de Quebec
- Alberta
  - Edmonton, Alberta, Canadá, T5H 3V9
    - Royal Alexandra Hospital
  - Edmonton, Alberta, Canadá, T6L 5X8
    - University of Alberta Hospital
- British Columbia
  - Calgary, British Columbia, Canadá, T2N 2T9
    - Foothills Medical Centre
  - New Westminster, British Columbia, Canadá, V3L 3W4
    - Royal Columbian Hospital
  - Vancouver, British Columbia, Canadá, V5Z 1M9
    - Vancouver General Hospital
  - Vancouver, British Columbia, Canadá, V6Z 1Y6
    - Interventional Cardiology Research, St. Paul's Hospital
  - Victoria, British Columbia, Canadá, V8R 4R2
    - Victoria Heart Institute Foundation
- Newfoundland and Labrador
  - St John's, Newfoundland and Labrador, Canadá, A1B 3V6
    - John Health Science Center
- Nova Scotia
  - Halifax, Nova Scotia, Canadá, B3H 3A7
    - Queen Elizabeth II - Health Sciences Centre
- Ontario
  - Cambridge, Ontario, Canadá, N1R 6V6
    - Cambridge Cardiac Care
  - Hamilton, Ontario, Canadá, L8L 2X2
    - McMaster Clinic Hamilton General Hospital
  - Kitchener, Ontario, Canadá, N2M 5N4
    - KMH Cardiology & Diagnostics Centre
  - Kitchener, Ontario, Canadá, N2M 1B2
    - St-Mary's Hospital
  - London, Ontario, Canadá, N6G 2V2
    - London Health Sciences Center
  - Mississauga, Ontario, Canadá, L5K 2L3
    - KMH Cardiology & Diagnostics Centre
  - Newmarket, Ontario, Canadá, L3Y 2R2
    - Southlake Regional Health Center
  - Oshawa, Ontario, Canadá, L1J 2J9
    - Heart Care Research
  - Ottawa, Ontario, Canadá, K1Y 4W7
    - University of Ottawa Heart Institute
  - Scarborough, Ontario, Canadá, M1E 5E9
    - Scarborough Cardiology Research
  - Toronto, Ontario, Canadá, M5G 2C4
    - University Health Network
  - Toronto, Ontario, Canadá, M4N 3M5
    - Sunnybrook Health Science Center
- Quebec
  - Chicoutimi, Quebec, Canadá, G7H 5H6
    - Complexe hospitalier de la Sagamie
  - Fleurimont, Quebec, Canadá, J1H 5N4
    - CHUS-Hopital Fleurimont
  - Gatineau, Quebec, Canadá, J8Y 6S9
    - CSSS-Hopital de Gatineau, secteur Hull
  - Greenfield Park, Quebec, Canadá, J4V 2G8
    - Viacar Recherche Clinique
  - Laval, Quebec, Canadá, H7M 3L9
    - CSSS de Laval
  - Longueuil, Quebec, Canadá, J4M 2X1
    - Hôpital Pierre Boucher
  - Montreal, Quebec, Canadá, H1T 1C8
    - Montreal Heart Institute
  - Montreal, Quebec, Canadá, H4J 1C5
    - Hôpital Sacré-Coeur de Montréal
  - Montreal, Quebec, Canadá, H2W 1T8
    - CHUM Hopital-Hôtel-Dieu
  - Montreal, Quebec, Canadá, H3G 1A4
    - CUSM Montreal General Hospital
  - Saint-Georges, Quebec, Canadá, G5Y 4T8
    - Centre de santé et des services sociaux de Beauce
  - St-Charles-Borromée, Quebec, Canadá, J6E 6J2
    - Centre hospitalier régional de Lanaudière
  - St-Jerome, Quebec, Canadá, J7Z 5T3
    - St-Jerome Medical Research Inc.
  - Toronto, Quebec, Canadá, M5B 1W8
    - St. Michael's Hospital
  - Trois-Rivières, Quebec, Canadá, G8Z 3R9
    - CHRTR de Trois-Rivières
  - Val D'Or, Quebec, Canadá, J9P 3Y1
    - CSSS Vallée de l'Or
- Saskatchewan
  - Saskatoon, Saskatchewan, Canadá, S7N OW8
    - Royal University Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients with clinical indication for coronary angiography

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
co-primary outcome measure - Nominal change from baseline in percent atheroma volume Prazo: 2 years	intravascular ultrasound measure	2 years
co-primary outcome measure - nominal change from baseline in carotid IMT Prazo: 2 years	2D B-mode carotid ultrasound measure	2 years

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
cardiovascular morbidity and mortality Prazo: 5 years	as adjudicated by a Clinical Endpoint Committee	5 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Canadian Atherosclerosis Imaging Network

Colaboradores

Canadian Institutes of Health Research (CIHR)

Investigadores

Cadeira de estudo: Jean-Claude Tardif, MD, Montreal Heart Institute

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Canadian Atherosclerosis Imaging Network (CAIN) - "Hearts and Minds"

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2010

Conclusão Primária (Real)

1 de dezembro de 2017

Conclusão do estudo (Real)