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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05344612
Other study ID # NL81264.018.22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 14, 2022
Est. completion date September 30, 2026

Study information

Verified date July 2023
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 6444
Est. completion date September 30, 2026
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
CT Coronary Angiography
Upfront ct-coronary angiography

Locations

Country Name City State
Netherlands Amsterdam UMC Amsterdam Noord-Holland

Sponsors (1)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite of all-cause mortality and non-fatal myocardial infarction 1 Year
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