| NCT ID | NCT06205810 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CoreAalst BV |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-10-24 |
| Primary Completion | 2030-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2023-10-24 with a primary completion date of 2030-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Eric Wyffels, MD, PhD
PRINCIPAL INVESTIGATOR
OLV Hospital Aalst
Frequently Asked Questions
Who can join the NCT06205810 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06205810 currently recruiting?
Yes, NCT06205810 is actively recruiting participants. Contact the research team at sofiepardaens@coreaalst.com for enrollment information.
Where is the NCT06205810 trial being conducted?
This trial is being conducted at Aalst, Belgium.
Who is sponsoring the NCT06205810 clinical trial?
NCT06205810 is sponsored by CoreAalst BV. The principal investigator is Eric Wyffels, MD, PhD at OLV Hospital Aalst. The trial plans to enroll 250 participants.