Clinical trial NCT03466255: Early Detection of Cardiovascular Disease
Official title: Vascular Imaging as a Barometer for the Early Detection of Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atheroma
Cardiac Disease
Vascular Diseases
Atherosclerosis
Myocardial Infarction
Acute Coronary Syndrome
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Lantheus Medical Imaging
First posted: 2018-03-15
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects referred for outpatient coronary angiography will be screened for inclusion.

Brief summary: The investigators plan to evaluate the correlation between carotid plaque enhancement on Contrast-enhanced ultrasound (CEUS), significant coronary artery disease (CAD), and cardiovascular (CV) outcomes in a systematic manner. The investigators hypothesize that increased levels of CEUS-detected vulnerable carotid plaque will be predictive of CV risk determined by angiography and future cardiovascular events.

Detailed description: Study Design: The investigators will conduct a prospective, single-center, observational study at the Cardiovascular Imaging Network at Queen's (CINQ, www.CINQLab.com). This facility allows a CEUS protocol to be conducted on the same day as the angiogram. It is anticipated that 100 participants can be recruited per month with a total target enrolment of up to 1000 participants.

Objectives

1. To determine the test characteristics (sensitivity, specificity, negative/positive predictive values) of carotid plaque by CEUS (Definity(R)) for predicting significant CAD (≥50% stenosis) in participants referred for angiography
2. To determine the test characteristics (sensitivity, specificity, predictive values) of carotid plaque by CEUS for predicting future CV events, such as death, stroke, myocardial infarction, and cardiovascular interventions.

Eligibility criteria: Inclusion criteria:

1. \>18 years of age
2. Outpatients referred for clinically indicated angiography for assessment of CAD
3. Low - Intermediate Framingham risk (\<20%)
4. Absence of clinical contraindication to angiography
5. Able and willing to give informed consent

Exclusion criteria:

1. Patients presenting with acute coronary syndrome
2. Patients with previously known significant CAD (any lesion \>50%) or percutaneous coronary intervention or coronary artery bypass surgery
3. Previous carotid surgery or angioplasty
4. Documented allergy to echo contrast

Primary outcomes:
measure: Maximum Plaque Height (physiological parameter)
timeFrame: 4 years
measure: Total Plaque Area (physiological parameter)
timeFrame: 4 years
measure: Neovascularization (contrast enhancement intensity) (physiological parameter)
timeFrame: 4 years
measure: Contrast wash-in time (physiological parameter)
timeFrame: 4 years
Secondary outcomes:
measure: Participants CV outcome follow-up (data linkage through the Institute for Clinical Evaluative Sciences: ICES)
timeFrame: 5 years
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University, Cardiovascular Imaging Network at Queen's (CINQ), Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Amer M Johri, MD
role: PRINCIPAL_INVESTIGATOR
References: