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NCT05416385Recruiting

Carotid Intraplaque Neovascularization Combined With Stress Echo

Combining Intraplaque Neovascularization With Risk Stratification by Carotid Stress ECHO

Source: ClinicalTrials.gov · Last updated 6 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1500 (estimated)
First submitted
8 Jun 2022
Start date
16 Aug 2021
Primary completion date
16 Aug 2026
Lead sponsor
Dr. Amer Johri
NCT number
NCT05416385

What you commit to

  • Study type: Observational
  • Planned participants: 1500
  • From 16 Aug 2021 to the primary completion date, 16 Aug 2026
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous enrolment into the study.

Other illness

  • Emergency procedure, or active acute coronary syndrome (active chest pain, ischemic electrocardiogram changes, or cardiac enzyme elevation);
  • Referral for viability, pulmonary hypertension, or valve assessment;
  • History of significant CAD: percutaneous coronary intervention (PCI), coronary artery bypass graft (GABG), or coronary angioplasty;
  • History of stroke or myocardial infarction (MI);
  • Known or documented hypersensitivity or allergy to perflutren (DEFINITY® contrast agent);
  • Known or documented allergy to Polyethylene Glycol (Peg) a component of DEFINITY®;
  • History of carotid surgery (endarterectomy or stenting);
  • Any serious medical condition or complication from the stress test that according to the investigator could interfere with the carotid scan or optimal care;

Other

  • Referral outside of the normal working hours;
  • Currently pregnant or breastfeeding;

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Of Calgary
Coordinator of this site? Confirm its status
CalgaryCanadaRecruiting
University of Alberta
Coordinator of this site? Confirm its status
EdmontonCanadaNot yet recruiting
Dalhousie University
Coordinator of this site? Confirm its status
HalifaxCanadaRecruiting
Queen's University, Cardiovascular Imaging Network at Queen's (CINQ)
Coordinator of this site? Confirm its status
KingstonCanadaRecruiting
The Kingston Heart Clinic
Coordinator of this site? Confirm its status
KingstonCanadaRecruiting
Unity Health Toronto
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.