Assessing heart disease risk using carotid ultrasound and stress tests

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to improve the accuracy of stress tests in predicting major cardiovascular events by combining carotid intraplaque neovascularization scoring with stress echocardiography. The primary objective is to evaluate whether this combined approach enhances the prediction of three-year major adverse cardiovascular events compared to stress echocardiography alone. By analyzing the percentage change in test sensitivity and the net reclassification improvement, the study seeks to identify patients at higher risk who may otherwise be missed by standard stress tests. The interventions involve the use of carotid contrast-enhanced ultrasound to assess plaque characteristics.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Calgary
  Calgary, Alberta, Canada Recruiting
• Dalhousie University
  Halifax, Nova Scotia, Canada Recruiting
• The Kingston Heart Clinic
  Kingston, Ontario, Canada Recruiting
• Queen's University, Cardiovascular Imaging Network at Queen's (CINQ)
  Kingston, Ontario, Canada Recruiting
• Unity Health Toronto
  Toronto, Ontario, Canada Recruiting
• University of Alberta
  Edmonton, Alberta, Canada Not yet recruiting

Study contacts

• Principal investigator: Amer Johri, MD — Queen's University
• Study coordinator: Marie-France Hetu, PhD
• Email: cinq.research@gmail.com
• Phone: 1 613-549-6666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.