The COMPLETE Study

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT06205810
• Lead Sponsor: CoreAalst BV

Brief Summary

The COMPLETE study is a single-centre, investigator-initiated study of patients with an indication for invasive coronary angiography with CCTA performed during the diagnostic evaluation. After identifying the presence of a coronary stenosis, defined as an epicardial lesion \>50% stenosis on CCTA, patients eligible for the study will be invited to participate.

The main aim of this trial is to assess the accuracy of coronary CT angiography to quantify total atheroma volume with intravascular ultrasound as reference.

Patients will be divided into 2 sub-groups:

Cohort 1: Patients with stable coronary artery disease or stabilized acute coronary syndromes with a clinical indication for invasive coronary angiography.

Cohort 2: Patients previously revascularized with a metallic stent with a clinical indication for invasive coronary angiography.

In both cohorts, patients should have undergone coronary CT angiography as part of the standard of care.

Patients included in the study will be managed according to the standard of care for the assessment of coronary artery disease. Clinical follow-up will be collected until 3 years follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-24
• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2024-01-03
• Study First Posted: 2024-01-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24
• Primary Completion: 2030-10
• Study Completion: 2031-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
assess the accuracy of CCTA to quantify total atheroma volume (TAV) with IVUS as reference.	day 0 (day of the procedure)	To assess the accuracy of CCTA (Coronary Computed Tomography Angiography) to quantify total atheroma volume (TAV) with IVUS (Intravascular Ultrasound) as reference.

Secondary Outcome Measures

Name	Time	Method
Assess the accuracy of CCTA to determine minimal stent area with IVUS as reference.	day 0 (day of the procedure)	To assess the accuracy of CCTA (Coronary Computed Tomography Angiography) to determine minimal stent area with IVUS (Intravascular Ultrasound) as reference.
Determine the diagnostic performance (mean difference) of FFRCT in stented segments with invasive FFR as reference.	day 0 (day of the procedure)	To determine the diagnostic performance (mean difference) of FFRCT (Fractional Flow Reserve derived from CT) in stented segments with invasive FFR (Fractional Flow Reserve ) as reference.
Describe the impact of coronary microvascular dysfunction assessed by IMR and absolute coronary resistance on the accuracy of FFRCT.	day 0 (day of the procedure	To describe the impact of coronary microvascular dysfunction assessed by IMR (Index of Microcirculatory Resistance) and absolute coronary resistance on the accuracy of FFRCT (Fractional Flow Reserve derived from CT).

Trial Locations

Locations (1)

OLV Hospital Aalst; 🇧🇪 Aalst, Oost-Vlaanderen, Belgium