The COMPLETE Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-24

Study Completion Date

2031-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI

NCT05786131

Non-ST-elevation Myocardial Infarction Multivessel Coronary Artery Disease

RECRUITING NA

Observational Registry on Clinical Outcome After Diagnosis of Chronic Total Occlusions

NCT04145167

Chronic Total Occlusion of Coronary Artery Angina Pectoris

UNKNOWN

Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

NCT05701358

Acute Myocardial Infarction Coronary Artery Disease

RECRUITING NA

Validation of Stenosis Assessment by Coronary Artery Computed Tomography Against Invasive Measurements of Fractional Flow Reserve in Patients With Significant Coronary Artery Stenoses

NCT00817102

Coronary Artery Stenosis

COMPLETED NA

QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions

NCT04808310

Coronary Artery Disease

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1\. Epicardial stenosis more than 50% by visual assessment.

Exclusion Criteria

1. STEMI.
2. Hemodynamic instability.
3. Rapid atrial fibrillation, flutter or arrhythmia (HR \> 80 bpm).
4. Insufficient CCTA image quality.
5. Age \<18 years.
6. Chronic obstructive pulmonary disease.
7. Contraindication to adenosine.
8. NYHA class III or IV, or last known left ventricular ejection fraction \<30%.
9. Uncontrolled or recurrent ventricular tachycardia.
10. History of recent stroke (≤90 days).
11. Prior myocardial infarction.
12. History of ischemic stroke (\>90 days) with modified RANKIN score ≥ 2.
13. History of any hemorrhagic stroke.
14. Previous coronary artery bypass surgery.
15. Active liver disease or hepatic dysfunction, defined as AST or ALT \> 3 times the ULN.
16. Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2.
17. BMI \>35 kg/m2.
18. Nitrate intolerance
19. Contra-indication to heart rate lowering drugs.
20. Unable to provide written informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No