The COMPLETE Study

Coronary Artery Disease Clinical Trial

— COMPLETE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205810
• Other study ID #: CA-063
• Status: Recruiting
• Start date: October 24, 2023
• Est. completion date: October 2028

Study information

• Verified date: January 2024
• Source: CoreAalst BV
• Contact: Sofie Pardaens, MSc, PhD
• Phone: 0032 53 72 42 30
• Email: sofiepardaens[@]coreaalst.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 2028
• Est. primary completion date: October 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Belgium	OLV Hospital Aalst	Aalst	Oost-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
CoreAalst BV	HeartFlow, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the accuracy of CCTA to quantify total atheroma volume (TAV) with IVUS as reference.	To assess the accuracy of CCTA (Coronary Computed Tomography Angiography) to quantify total atheroma volume (TAV) with IVUS (Intravascular Ultrasound) as reference.	day 0 (day of the procedure)
Secondary	Assess the accuracy of CCTA to determine minimal stent area with IVUS as reference.	To assess the accuracy of CCTA (Coronary Computed Tomography Angiography) to determine minimal stent area with IVUS (Intravascular Ultrasound) as reference.	day 0 (day of the procedure)
Secondary	Determine the diagnostic performance (mean difference) of FFRCT in stented segments with invasive FFR as reference.	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.	day 0 (day of the procedure)
Secondary	Describe the impact of coronary microvascular dysfunction assessed by IMR and absolute coronary resistance on the accuracy of FFRCT.	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).	day 0 (day of the procedure