Carotid Intraplaque Neovascularization Combined With Stress Echo (CIRCE)

November 23, 2023 updated by: Dr. Amer Johri

Combining Intraplaque Neovascularization With Risk Stratification by Carotid Stress ECHO

The root cause of heart attacks and strokes is atherosclerosis, the hardening and thickening of blood vessels due to the presence of "plaque" which is a build-up of fat and cholesterol in the walls of vessels. To diagnose heart disease, patients receive a stress test to find out if they require surgery. Up to 52% of patients receiving an angiogram (surgery) to look at plaque blockages in the heart are found to be normal (no blockage). Patients who are suspected of having heart disease often undergo a stress test, which helps cardiologists decide if the patient has heart disease, but stress tests can give false results. In Ontario alone, 90% are stress tests are found to be normal and patients are sent home with little follow-up. Of these 3-5% (~4,000 patients/year) will have a major cardiovascular event (heart attack, surgery, or death) within 3 years. We need to improve the stress test accuracy to reduce cardiac outcome. We now know that it is not just the total amount of plaque that leads to heart attacks and strokes, but the composition of the plaque that can lead to breakage causing a heart attack. Plaques are soft and fragile, and typically contain fat and small leaky blood vessels within their cores. If we are able to identify patients that have leaky plaques using ultrasound, we may be able to improve the accuracy of stress testing. We propose a study looking at the combination of stress testing (assessing heart function) and neck ultrasound (assessing plaque composition), to identify patients at risk for cardiovascular events (heart attacks and death). We will enrol patients from 6 sites across Canada and follow-them for cardiac outcome for 3 years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Aim: To determine if carotid intraplaque neovascularization score (IPN) combined with stress echo (SE) [IPN+SE] enhances prediction of 3-year major adverse cardiovascular events (MACE) compared to SE alone.

Objectives: 1) The % change in test sensitivity of IPN+SE for predicting 3-year MACE compared with SE alone. 2) The Net Reclassification Improvement (NRI) for MACE will be determined (patients "missed" by the SE, but captured as high risk for MACE by IPN).

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Not yet recruiting
        • University of Calgary
        • Principal Investigator:
          • Omid Kiamanesh, MD
        • Principal Investigator:
          • Nowell Fine, MD SM FRCPC
      • Edmonton, Alberta, Canada, T6G 2R3
        • Not yet recruiting
        • University of Alberta
        • Contact:
        • Principal Investigator:
          • Harald Becher, MD, PhD FRCP
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Not yet recruiting
        • Dalhousie University
        • Principal Investigator:
          • Sharon Mulvagh, MD, FRCPC
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Queen's University, Cardiovascular Imaging Network at Queen's (CINQ)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Low to intermediate risk outpatient subjects referred for stress echo (SE) for assessment of ischemia and risk stratification will be screened for inclusion.

Description

Inclusion Criteria:

  1. Men and women >18 years;
  2. Referred for a clinically indicated SE for assessment of ischemia and risk stratification;
  3. Able and willing to give informed consent.

Exclusion Criteria:

  1. Emergency procedure, or active acute coronary syndrome (active chest pain, ischemic electrocardiogram changes, or cardiac enzyme elevation);
  2. Referral for viability, pulmonary hypertension, or valve assessment;
  3. Referral outside of the normal working hours;
  4. History of significant CAD: percutaneous coronary intervention (PCI), coronary artery bypass graft (GABG), or coronary angioplasty;
  5. History of stroke or myocardial infarction (MI);
  6. Known or documented hypersensitivity or allergy to perflutren (DEFINITY® contrast agent);
  7. Known or documented allergy to Polyethylene Glycol (Peg) a component of DEFINITY®;
  8. History of carotid surgery (endarterectomy or stenting);
  9. Any serious medical condition or complication from the stress test that according to the investigator could interfere with the carotid scan or optimal care;
  10. Currently pregnant or breastfeeding;
  11. Previous enrolment into the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac outpatients
Subjects referred for outpatient stress echocardiogram (SE).
Other: Carotid Contrast Enhanced Ultrasound
Carotid Contrast-Enhanced Ultrasound (CEUS), a diagnostic ultrasound enhancing agent that opacifies the blood to delineate the vessel walls.
Other Names:
  • Contrast injection, DEFINITY®, Perflutren Lipid Microsphere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Our primary outcomes will be the improvement in sensitivity and negative predictive value (NPV).
Time Frame: This is a 5-year study. The outcome follow up for mace will be 3-years from the index date (SE).
Our primary analysis will compare the sensitivity of an established binary test based on SE alone to a binary test based on SE and plaque assessment (using established thresholds, IPN≥1.25) to predict 3-year MACE.
This is a 5-year study. The outcome follow up for mace will be 3-years from the index date (SE).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Amer Johri

Collaborators

Lantheus Medical Imaging

Investigators

  • Principal Investigator: Amer Johri, MD, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2021

Primary Completion (Estimated)

August 16, 2026

Study Completion (Estimated)

August 16, 2026

Study Registration Dates

First Submitted

June 8, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 13, 2022

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMED-2469-21-6032717
  • CG#21007 (Other Grant/Funding Number: Lantheus Medical Imaging, Inc.)
  • 452696 (Other Identifier: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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