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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01353612
Recruitment Status : Unknown
Verified January 2015 by Canadian Atherosclerosis Imaging Network.
Recruitment status was:  Active, not recruiting
First Posted : May 13, 2011
Last Update Posted : February 4, 2015
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Canadian Atherosclerosis Imaging Network

Brief 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.

Condition or disease

Detailed 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.

Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
Study Start Date : January 2010
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Primary Outcome Measures :
  1. co-primary outcome measure - Nominal change from baseline in percent atheroma volume [ Time Frame: 2 years ]
    intravascular ultrasound measure

  2. co-primary outcome measure - nominal change from baseline in carotid IMT [ Time Frame: 2 years ]
    2D B-mode carotid ultrasound measure

Secondary Outcome Measures :
  1. cardiovascular morbidity and mortality [ Time Frame: 5 years ]
    as adjudicated by a Clinical Endpoint Committee

Biospecimen Retention:   Samples With DNA
samples stored for potential correlation with imaging and cardiovascular outcomes endpoints in subset of patients (optional)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with clinical indication for coronary angiography

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01353612

  Show 39 Study Locations
Sponsors and Collaborators
Canadian Atherosclerosis Imaging Network
Canadian Institutes of Health Research (CIHR)
Study Chair: Jean-Claude Tardif, MD Montreal Heart Institute

Responsible Party: Canadian Atherosclerosis Imaging Network Identifier: NCT01353612     History of Changes
Other Study ID Numbers: CAIN-003
First Posted: May 13, 2011    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Carotid Artery Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases