Status:
RECRUITING
The COMPLETE Study
Lead Sponsor:
CoreAalst BV
Collaborating Sponsors:
HeartFlow, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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 identif...
Eligibility Criteria
Inclusion
- 1\. Epicardial stenosis more than 50% by visual assessment.
Exclusion
- STEMI.
- Hemodynamic instability.
- Rapid atrial fibrillation, flutter or arrhythmia (HR \> 80 bpm).
- Insufficient CCTA image quality.
- Age \<18 years.
- Chronic obstructive pulmonary disease.
- Contraindication to adenosine.
- NYHA class III or IV, or last known left ventricular ejection fraction \<30%.
- Uncontrolled or recurrent ventricular tachycardia.
- History of recent stroke (≤90 days).
- Prior myocardial infarction.
- History of ischemic stroke (\>90 days) with modified RANKIN score ≥ 2.
- History of any hemorrhagic stroke.
- Previous coronary artery bypass surgery.
- Active liver disease or hepatic dysfunction, defined as AST or ALT \> 3 times the ULN.
- Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2.
- BMI \>35 kg/m2.
- Nitrate intolerance
- Contra-indication to heart rate lowering drugs.
- Unable to provide written informed consent.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2031
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06205810
Start Date
October 24 2023
End Date
October 1 2031
Last Update
January 24 2025
Active Locations (1)
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1
OLV Hospital Aalst
Aalst, Oost-Vlaanderen, Belgium, 9300