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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353612
• Other study ID #: CAIN-003
• Status: Completed
• Start date: January 2010
• Est. completion date: December 2017

Study information

• Verified date: February 2020
• Source: Canadian Atherosclerosis Imaging Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1626
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	British Columbia
Canada	Cambridge Cardiac Care	Cambridge	Ontario
Canada	Complexe Hospitalier de la Sagamie	Chicoutimi	Quebec
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
Canada	CSSS-Hopital de Gatineau, secteur Hull	Gatineau	Quebec
Canada	Viacar Recherche Clinique	Greenfield Park	Quebec
Canada	Queen Elizabeth II - Health Sciences Centre	Halifax	Nova Scotia
Canada	McMaster Clinic Hamilton General Hospital	Hamilton	Ontario
Canada	KMH Cardiology & Diagnostics Centre	Kitchener	Ontario
Canada	St-Mary's Hospital	Kitchener	Ontario
Canada	CSSS de Laval	Laval	Quebec
Canada	London Health Sciences Center	London	Ontario
Canada	Hopital Pierre Boucher	Longueuil	Quebec
Canada	KMH Cardiology & Diagnostics Centre	Mississauga	Ontario
Canada	CHUM Hopital-Hôtel-Dieu	Montreal	Quebec
Canada	CUSM Montreal General Hospital	Montreal	Quebec
Canada	Hopital Sacré-Cœur de Montreal	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Southlake Regional Health Center	Newmarket	Ontario
Canada	Heart Care Research	Oshawa	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec
Canada	Centre de santé et des services sociaux de Beauce	Saint-Georges	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Scarborough Cardiology Research	Scarborough	Ontario
Canada	John Health Science Center	St John's	Newfoundland and Labrador
Canada	Centre Hospitalier Régional de Lanaudière	St-Charles-Borromée	Quebec
Canada	St-Jerome Medical Research Inc.	St-Jerome	Quebec
Canada	St. Michael's Hospital	Toronto	Quebec
Canada	Sunnybrook Health Science Center	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	CHRTR de Trois-Rivières	Trois-Rivières	Quebec
Canada	CSSS Vallée de l'Or	Val D'Or	Quebec
Canada	Interventional Cardiology Research, St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Victoria Heart Institute Foundation	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Atherosclerosis Imaging Network	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	co-primary outcome measure - Nominal change from baseline in percent atheroma volume	intravascular ultrasound measure	2 years
Primary	co-primary outcome measure - nominal change from baseline in carotid IMT	2D B-mode carotid ultrasound measure	2 years
Secondary	cardiovascular morbidity and mortality	as adjudicated by a Clinical Endpoint Committee	5 years

External Links

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