NCT05344612 Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD
| NCT ID | NCT05344612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Chest Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,444 participants |
| Start Date | 2022-09-14 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6,444 participants in total. It began in 2022-09-14 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rationale: Patients with chest pain usually undergo multiple diagnostic examinations to demonstrate or rule out atherosclerotic coronary artery disease (CAD). In addition to high healthcare costs, some of the examinations do not assess the presence of CAD, which means that patients may be undertreated and are at risk for myocardial infarction. A uniform diagnostic and treatment strategy that uses computed tomography coronary angiography (CTCA) as initial examination may reduce major adverse cardiac events (MACE) and may reduce healthcare costs. In addition, we hypothesize that this strategy improves angina-related health status and reduces the number of invasive coronary angiograms (CAG's). Objectives: * To show that the intervention is non-inferior to the control with regards to clinical outcomes * To show superiority of the intervention with regards to clinical outcomes Study design: National multicenter prospective randomized controlled trial. Study population: Patients with suspected stable CAD. Intervention: upfront CTCA to diagnose CAD and guide optimal medical therapy (OMT). Patients with obstructive CAD and refractory angina despite OMT will undergo non-invasive ischemia imaging to guide revascularization. Control: Standard of care. Diagnosis and treatment are at the discretion of the attending cardiologist. Main study end point: Composite of all-cause mortality and non-fatal myocardial infarction.
Eligibility Criteria
Inclusion Criteria: * \>18 years Exclusion Criteria: * Presentation with acute coronary syndrome * Acute coronary syndrome within last 3 months * History of obstructive coronary artery disease on imaging * History of PCI and/or CABG * Severe renal failure * Severe allergy to ionidated contrast medium * Known pregnancy * Patients with an estimated life expectancy of less than 1 year
Frequently Asked Questions
Who can join the NCT05344612 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chest Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05344612 currently recruiting?
Yes, NCT05344612 is actively recruiting participants. Visit ClinicalTrials.gov or contact Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) to inquire about joining.
Where is the NCT05344612 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05344612 clinical trial?
NCT05344612 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 6,444 participants.