The COMPLETE Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comprehensive Anatomical and Physiological Evaluation of Patients With Stable Coronary Artery Disease.
Overview
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.
Primary outcome measures
- assess the accuracy of CCTA to quantify total atheroma volume (TAV) with IVUS as reference. [Time frame: day 0 (day of the procedure)]
Secondary outcome measures (3)
- Assess the accuracy of CCTA to determine minimal stent area with IVUS as reference. [Time frame: day 0 (day of the procedure)]
- Determine the diagnostic performance (mean difference) of FFRCT in stented segments with invasive FFR as reference. [Time frame: day 0 (day of the procedure)]
- Describe the impact of coronary microvascular dysfunction assessed by IMR and absolute coronary resistance on the accuracy of FFRCT. [Time frame: day 0 (day of the procedure]
Eligibility criteria
Inclusion criteria
1\. Epicardial stenosis more than 50% by visual assessment.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- OLV Hospital Aalst — Aalst
Identifiers
NCT: NCT06205810 · CA-063