An observational study in Atherosclerosis, Cardiovascular Diseases and Acute Coronary Syndrome, sponsored by Dr. Amer Johri. Recruiting at 6 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Dr. Amer Johri · Observational
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.
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).
1,596 studies on the registry are indexed under Atherosclerosis; 262 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 230 across 581 observational studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Dr. Amer Johri is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Low to intermediate risk outpatient subjects referred for stress echo (SE) for assessment of ischemia and risk stratification will be screened for inclusion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Also known as: Contrast injection, DEFINITY®, Perflutren Lipid Microsphere
Our primary outcomes will be the improvement in sensitivity and negative predictive value (NPV).
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.
Time frame: This is a 5-year study. The outcome follow up for mace will be 3-years from the index date (SE).
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2021 (actual). Primary completion is estimated for Aug 2026, 60 months after the start.
Of 173 non-industry observational studies under Atherosclerosis, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 153. This study's planned 60 months is close to that.
Counting every sponsor, half of 198 studies reached it within 54 months; a quarter within 31 and three quarters within 129.
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Dr. Amer Johri