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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Canadian Atherosclerosis Imaging Network
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Canadian Atherosclerosis Imaging Network
ClinicalTrials.gov Identifier:
NCT01353612
First received: May 12, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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
Atherosclerosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes

Resource links provided by NLM:


Further study details as provided by Canadian Atherosclerosis Imaging Network:

Estimated Enrollment: 2000
Study Start Date: January 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with clinical indication for coronary angiography

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353612

Contacts
Contact: Angel Khaznadjian, M.Sc. 514-461-1300 ext 2053 angel.khaznadjian@mhicc.org

  Show 40 Study Locations
Sponsors and Collaborators
Canadian Atherosclerosis Imaging Network
Canadian Institutes of Health Research (CIHR)
Investigators
Study Chair: Jean-Claude Tardif, MD Montreal Heart Institute
  More Information

No publications provided

Responsible Party: Canadian Atherosclerosis Imaging Network
ClinicalTrials.gov Identifier: NCT01353612     History of Changes
Other Study ID Numbers: CAIN-003
Study First Received: May 12, 2011
Last Updated: June 23, 2014
Health Authority: Canada: Canadian Institutes of Health Research

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

ClinicalTrials.gov processed this record on October 01, 2014