Clinical trial NCT06205810: The COMPLETE Study
Official title: Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: FFRCT
Lead sponsor: CoreAalst BV
Sponsor class: INDUSTRY
Collaborators: name: HeartFlow, Inc.
First posted: 2024-01-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Coronary Artery Disease with an epicardial stenosis of more than 50% of visual assessment.

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.


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.

Primary outcomes:
measure: assess the accuracy of CCTA to quantify total atheroma volume (TAV) with IVUS as reference.
timeFrame: day 0 (day of the procedure)
Secondary outcomes:
measure: Assess the accuracy of CCTA to determine minimal stent area with IVUS as reference.
timeFrame: day 0 (day of the procedure)
measure: Determine the diagnostic performance (mean difference) of FFRCT in stented segments with invasive FFR as reference.
timeFrame: day 0 (day of the procedure)
measure: Describe the impact of coronary microvascular dysfunction assessed by IMR and absolute coronary resistance on the accuracy of FFRCT.
timeFrame: day 0 (day of the procedure
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital Aalst
state: Oost-Vlaanderen
Study officials:
affiliation: OLV Hospital Aalst
name: Eric Wyffels, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: