Assessing coronary artery disease using CT angiography

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

The COMPLETE study is an observational study focusing on patients who require invasive coronary angiography after undergoing coronary CT angiography (CCTA). It aims to evaluate the accuracy of CCTA in quantifying total atheroma volume, using intravascular ultrasound as a reference standard. Participants will be divided into two cohorts: those with stable coronary artery disease or stabilized acute coronary syndromes, and those previously revascularized with a metallic stent. Eligible patients must have significant epicardial stenosis identified through CCTA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1\. Epicardial stenosis more than 50% by visual assessment.

Exclusion Criteria:

1. STEMI.
2. Hemodynamic instability.
3. Rapid atrial fibrillation, flutter or arrhythmia (HR \> 80 bpm).
4. Insufficient CCTA image quality.
5. Age \<18 years.
6. Chronic obstructive pulmonary disease.
7. Contraindication to adenosine.
8. NYHA class III or IV, or last known left ventricular ejection fraction \<30%.
9. Uncontrolled or recurrent ventricular tachycardia.
10. History of recent stroke (≤90 days).
11. Prior myocardial infarction.
12. History of ischemic stroke (\>90 days) with modified RANKIN score ≥ 2.
13. History of any hemorrhagic stroke.
14. Previous coronary artery bypass surgery.
15. Active liver disease or hepatic dysfunction, defined as AST or ALT \> 3 times the ULN.
16. Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2.
17. BMI \>35 kg/m2.
18. Nitrate intolerance
19. Contra-indication to heart rate lowering drugs.
20. Unable to provide written informed consent.

Where it's running

• OLV Hospital Aalst
  Aalst, Oost-Vlaanderen, Belgium Recruiting

Study contacts

• Principal investigator: Eric Wyffels, MD, PhD — OLV Hospital Aalst
• Study coordinator: Sofie Pardaens, MSc, PhD
• Email: sofiepardaens@coreaalst.com
• Phone: 0032 53 72 42 30

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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.