Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
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Purpose
This is a prospective, multi-center imaging study expecting to enroll approximately 2000 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and Locations| Contact: Jean-Claude Tardif, MD | 514-376-3330 ext 3612 | jean-claude.tardif@icm-mhi.org |
Show 38 Study Locations| Study Chair: | Jean-Claude Tardif, MD | Montreal Heart Institute |
More Information
No publications provided
| Responsible Party: | Dr. Jean-Claude Tardif, Montreal Heart Institute |
| ClinicalTrials.gov Identifier: | NCT01353612 History of Changes |
| Other Study ID Numbers: | CAIN-003 |
| Study First Received: | May 12, 2011 |
| Last Updated: | July 12, 2011 |
| Health Authority: | Canada: Canadian Institutes of Health Research |
Additional relevant MeSH terms:
|
Atherosclerosis Carotid Artery Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Cardiovascular Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013