NCT06205810Recruiting
The COMPLETE Study
Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease.
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 28 Nov 2023
- Start date
- 24 Oct 2023
- Primary completion date
- 15 Oct 2030
- Lead sponsor
- CoreAalst BV
- Diseases
- Coronary artery disease
- NCT number
- NCT06205810
What you commit to
- Study type: Observational
- Planned participants: 250
- From 24 Oct 2023 to the primary completion date, 15 Oct 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior myocardial infarction.
- Previous coronary artery bypass surgery.
Other illness
- Rapid atrial fibrillation, flutter or arrhythmia (HR \> 80 bpm).
- Chronic obstructive pulmonary disease.
- History of recent stroke (≤90 days).
- History of ischemic stroke (\>90 days) with modified RANKIN score ≥ 2.
- History of any hemorrhagic stroke.
- Contra-indication to heart rate lowering drugs.
Lab values
- NYHA class III or IV, or last known left ventricular ejection fraction \<30%.
- 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.
Age
- Age \<18 years.
Other
- STEMI.
- Hemodynamic instability.
- Insufficient CCTA image quality.
- Contraindication to adenosine.
- Uncontrolled or recurrent ventricular tachycardia.
- BMI \>35 kg/m2.
- Nitrate intolerance
- Unable to provide written informed consent.
Who the study is looking for
- 1\. Epicardial stenosis more than 50% by visual assessment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OLV Hospital Aalst Coordinator of this site? Confirm its status | Aalst | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.