Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD

Recruiting now · Not applicable

Conditions studied: Chest Pain, CAD

In brief

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.

Key facts

Study ID

NCT05344612

Run by

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

People needed

6444

Starts

2022-09-14

Expected to finish

2026-09-30

Last updated by the study team

2023-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >18 years

You may not qualify if…

• 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

Where it is running

• Amsterdam UMC — Amsterdam, North Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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