Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT Coronary Angiography.
- Who it may be relevant to
- Registry conditions: Chest Pain, CAD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Outcomes and Cost-effectiveness of a Diagnostic and Treatment Strategy of Upfront CTCA Plus Selective Non-invasive Functional Imaging Compared With Standard Care in Patients With Chest Pain and Suspected Coronary Artery Disease
Overview
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.
Interventions
- Radiation CT Coronary Angiography
Upfront ct-coronary angiography
Primary outcome measures
- Composite of all-cause mortality and non-fatal myocardial infarction [Time frame: 1 Year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Netherlands · 1 center
- Amsterdam UMC — Amsterdam
Identifiers
NCT: NCT05344612 · NL81264.018.22