Actively Recruiting
Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2023-07-20
6444
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
You will not qualify if you...
- 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 iodinated contrast medium
- Known pregnancy
- Patients with an estimated life expectancy of less than 1 year
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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