Actively Recruiting

Age: 18Years +
All Genders
ID05416385

Combining Intraplaque Neovascularization With Risk Stratification by Carotid Stress Echocardiogram for Predicting Cardiovascular Events

Led by Dr. Amer Johri · Updated on 2025-02-06

1500

Participants Needed

6

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Dr. Amer Johri

Lead Sponsor

L

Lantheus Medical Imaging

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying adults with suspected heart disease to see if combining two tests—stress echocardiogram (SE) and carotid intraplaque neovascularization (IPN) ultrasound—can better predict serious heart problems over three years. The study addresses the challenge that many patients with normal stress tests still experience heart attacks or other major cardiac events later. By focusing on the composition of artery plaque, not just its amount, the study aims to improve early detection of risk for heart attacks and strokes. Participants will undergo a clinically ordered stress echocardiogram and an additional carotid contrast-enhanced ultrasound to assess plaque characteristics in the neck arteries. The study does not involve treatment but observes how combining these imaging methods may improve risk prediction. Patients referred for outpatient stress echocardiograms will be enrolled and followed for three years to track major adverse cardiovascular events (MACE). During the study, participants’ heart function and artery plaque will be evaluated using ultrasound imaging. Researchers will collect data on cardiac outcomes over three years after the initial tests. The main measurement is whether the combined test improves the ability to predict serious heart events compared to stress echocardiogram alone. The total study duration is five years, including follow-up, and participants will be monitored without any changes to their usual medical care.

CONDITIONS

Brief Title

Carotid Intraplaque Neovascularization Combined With Stress Echo

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women over 18 years old
  • Referred for a clinically indicated stress echocardiogram to assess ischemia and risk
  • Able and willing to give informed consent
Not Eligible

You will not qualify if you...

  • Emergency procedure or active acute coronary syndrome (active chest pain, ischemic ECG changes, or elevated cardiac enzymes)
  • Referred for viability, pulmonary hypertension, or valve assessment
  • Referred outside normal working hours
  • History of significant coronary artery disease, including PCI, coronary artery bypass graft, or angioplasty
  • History of stroke or myocardial infarction
  • Known allergy to perflutren contrast agent or Polyethylene Glycol (Peg)
  • History of carotid artery surgery (endarterectomy or stenting)
  • Serious medical condition or complications from stress test affecting carotid scan or care
  • Currently pregnant or breastfeeding
  • Previous enrollment in this study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Single visit

Participants undergo carotid contrast-enhanced ultrasound combined with stress echocardiogram to assess cardiovascular risk.

1 visit (in-person)

Long-term Monitoring

Duration - 3 years

Participants are monitored for major adverse cardiovascular events over 3 years following the diagnostic evaluation.

Trial Site Locations

Total: 6 locations

1

University of Calgary

Calgary, Alberta, Canada, T2N 1N4

Actively Recruiting

2

University of Alberta

Edmonton, Alberta, Canada, T6G 2R3

Not Yet Recruiting

3

Dalhousie University

Halifax, Nova Scotia, Canada, B3H 3A7

Actively Recruiting

4

The Kingston Heart Clinic

Kingston, Ontario, Canada, K7L 1C2

Actively Recruiting

5

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

Kingston, Ontario, Canada, K7L 2V7

Actively Recruiting

6

Unity Health Toronto

Toronto, Ontario, Canada, M5B 1W8

Actively Recruiting

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Research Team

M

Marie-France Hetu, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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