Early Detection of Cardiovascular Disease

NCT03466255 | Completed

• 3 other identifiers: DMED-1927-16CG#17006ER15-11-029
• Study Type: observational
• Target: 610
• Locations: 1 country
• Sites: 1

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.

Conditions

Atheroma; Cardiac Disease; Vascular Diseases; Atherosclerosis; Myocardial Infarction; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (4)

• Maximum Plaque Height (physiological parameter)

  Caliper measurement of carotid plaque height on ultrasound images, using GE EchoPAC software. The maximum height of either side will be used to correlate to severity of angiographic CAD and neovascularization score.

  4 years

• Total Plaque Area (physiological parameter)

  Area measurement of carotid plaque on ultrasound images (right + left side), using GE EchoPAC software. The total plaque area will be used to correlate to severity of angiographic CAD and neovascularization score.

  4 years

• Neovascularization (contrast enhancement intensity) (physiological parameter)

  A neovascularization score will be used to grade the "activity" of the carotid plaque per participants and be correlated to angiographic CAD, visualized and manually counted using GE EchoPAC software.

  4 years

• Contrast wash-in time (physiological parameter)

  Time of contrast entering the plaque will be assessed to see if it correlates to severity of angiographic CAD, using GE EchoPAC software.

  4 years

Secondary Outcomes (1)

• Participants CV outcome follow-up (data linkage through the Institute for Clinical Evaluative Sciences: ICES)

  5 years

Study Arms (1)

Cardiac outpatients

Subjects referred for outpatient coronary angiography.

Other: Ultrasound

Interventions

Ultrasound OTHER

Contrast-enhanced ultrasound (CEUS)

Also known as: Contrast injection - Definity(R)

Cardiac outpatients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects referred for outpatient coronary angiography will be screened for inclusion.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Amer Johri: lead
• Lantheus Medical Imaging: collaborator

Study Sites (1)

Queen's University, Cardiovascular Imaging Network at Queen's (CINQ), Kingston General Hospital

Kingston, Ontario, K7L 3N6, Canada

Location

Related Links

• Cardiovascular Imaging Network at Queen's

MeSH Terms

Conditions

Plaque, Atherosclerotic; Heart Diseases; Vascular Diseases; Atherosclerosis; Myocardial Infarction; Acute Coronary Syndrome

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Ischemia; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Amer M Johri, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 15, 2018
• Study Start: December 6, 2016
• Primary Completion: June 8, 2021
• Study Completion: January 11, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)