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Taking people in BelgiumNo phase

Compares CT heart scans with ultrasound inside the coronary arteries

Checks how well heart CT scans measure plaque in narrowed heart arteries, in adults.

Plain-language title generated from the registry record
Registry title: The COMPLETE Study

Key facts

Where
Aalst, BelgiumSee the site

Where in Belgium

  • OLV Hospital AalstAalst, BelgiumTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
CoreAalst BV
Trial code
NCT06205810
Record updated
20 January 2026
Original description
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.Read full original descriptionShow less

Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease.

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.

Inclusion: Epicardial stenosis more than 50% by visual assessment.

Exclusion: Prior myocardial infarction; Previous coronary artery bypass surgery; 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; 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 <18 years; 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.

ClinicalTrials.gov NCT06205810