Actively Recruiting

Age: 18Years +
All Genders
NCT06205810

The COMPLETE Study

Led by CoreAalst BV · Updated on 2026-01-20

250

Participants Needed

1

Research Sites

416 weeks

Total Duration

On this page

Sponsors

C

CoreAalst BV

Lead Sponsor

H

HeartFlow, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The COMPLETE Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Epicardial stenosis more than 50% by visual assessment.
  • Age 18 years or older.
Not Eligible

You will not qualify if you...

  • STEMI (ST-elevation myocardial infarction).
  • Hemodynamic instability.
  • Rapid atrial fibrillation, flutter, or arrhythmia with heart rate over 80 bpm.
  • Poor quality of coronary CT angiography images.
  • Age under 18 years.
  • Chronic obstructive pulmonary disease.
  • Contraindication to adenosine.
  • New York Heart Association (NYHA) class III or IV heart failure or left ventricular ejection fraction less than 30%.
  • Uncontrolled or recurrent ventricular tachycardia.
  • History of recent stroke within 90 days.
  • Prior myocardial infarction.
  • History of ischemic stroke more than 90 days ago with modified RANKIN score of 2 or higher.
  • History of any hemorrhagic stroke.
  • Previous coronary artery bypass surgery.
  • Active liver disease or liver dysfunction with AST or ALT levels more than 3 times the upper limit.
  • Severe kidney dysfunction with estimated glomerular filtration rate less than 30 mL/min/1.73 m2.
  • Body mass index over 35 kg/m2.
  • Nitrate intolerance.
  • Contraindication to heart rate lowering drugs.
  • Unable to provide written informed consent.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

OLV Hospital Aalst

Aalst, Oost-Vlaanderen, Belgium, 9300

Actively Recruiting

Loading map...

Research Team

S

Sofie Pardaens, MSc, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here