Amsterdam UMC
Amsterdam, North Holland, 1105 AZ, Netherlands
Location status: Recruiting
Location contact
Casper F Coerkamp, MD
CONTACT
José PS Henriques, prof. dr.
CONTACT
NCT Number: NCT05344612
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Amsterdam, North Holland, 1105 AZ, Netherlands
Location status: Recruiting
Casper F Coerkamp, MD
CONTACT
José PS Henriques, prof. dr.
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Upfront ct-coronary angiography
Time frame: 1 Year
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
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
Acronym: CLEAR-CAD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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