The COMPLETE Study

Recruiting now

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT06205810

Run by

CoreAalst BV

People needed

250

Starts

2023-10-24

Expected to finish

2031-10-15

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Epicardial stenosis more than 50% by visual assessment.

You may not qualify if…

• 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.

Where it is running

• OLV Hospital Aalst — Aalst, Oost-Vlaanderen, Belgium (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.