Assessing coronary artery disease using CT angiography

Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease.

This study is testing how well a special heart scan called CT angiography can measure heart artery blockages in patients who need further heart tests.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CoreAalst BV (Industry-sponsored)
• Locations: 1 site (Aalst, Oost-Vlaanderen)
• Trial ID: NCT06205810 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with epicardial stenosis greater than 50% who are indicated for invasive coronary angiography.

Not a fit: Patients with conditions such as STEMI, severe arrhythmias, or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the diagnostic accuracy for coronary artery disease, leading to better patient management and outcomes.

How similar studies have performed: Other studies have shown promising results in using CCTA for coronary artery disease assessment, indicating that this approach is supported by prior research.

Eligibility criteria

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 this trial is running

Aalst, Oost-Vlaanderen

• 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

Conditions Coronary Artery Disease; FFRCT