Actively Recruiting
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
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2023-07-20
6444
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate a diagnostic and treatment approach for patients experiencing chest pain who may have stable coronary artery disease (CAD). The study compares a new strategy using computed tomography coronary angiography (CTCA) as the first test against standard care, which depends on the attending cardiologist's judgment. The goal is to see if the CTCA-based approach is at least as effective as standard care in preventing major heart problems and possibly better in improving patient health and reducing invasive tests. Participants in the study are randomly assigned to one of two groups. The experimental group undergoes upfront CT coronary angiography to diagnose CAD and guide optimal medical treatment. If obstructive CAD is found and chest pain persists despite medication, further non-invasive imaging helps guide possible revascularization. The control group receives usual care without a set diagnostic protocol. This study is conducted across multiple centers and follows patients for clinical outcomes. During the study, researchers will monitor participants for the combined outcome of death from any cause or non-fatal heart attacks over one year. They will also assess the health status related to chest pain and record the number of invasive coronary angiograms performed. This trial helps determine if starting with CTCA can improve clinical outcomes and reduce healthcare costs. Participation involves regular assessments and follow-up to track these measures until the study ends in 2026.
CONDITIONS
Brief 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 18 years or older
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 ionidated contrast medium
- Known pregnancy
- Patients with an estimated life expectancy of less than 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants undergo diagnostic assessment with CT coronary angiography or standard care to evaluate chest pain and suspected coronary artery disease.
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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