NCT05416385

Carotid Intraplaque Neovascularization Combined With Stress Echo

Combining Intraplaque Neovascularization With Risk Stratification by Carotid Stress ECHO

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Dr. Amer Johri · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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).

Conditions

• Atherosclerosis
• Cardiovascular Diseases
• Acute Coronary Syndrome
• Ischemic Heart Disease
• Myocardial Infarction
• Carotid Artery Diseases

Interventions

Type	Name	Description
OTHER	Carotid Contrast Enhanced Ultrasound	Carotid Contrast-Enhanced Ultrasound (CEUS), a diagnostic ultrasound enhancing agent that opacifies the blood to delineate the vessel walls.

Timeline

• Start date: 2021-08-16
• Primary completion: 2026-08-16
• Completion: 2026-08-16
• First posted: 2022-06-13
• Last updated: 2025-02-06

Locations

6 sites across 1 country: Canada