Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD

Not Applicable

Recruiting

• Conditions: CAD; Chest Pain
• Interventions: Radiation: CT Coronary Angiography

• Registration Number: NCT05344612
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-25
• Study Start: 2022-09-14
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20
• Primary Completion: 2025-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6444

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTCA	CT Coronary Angiography	-

Primary Outcome Measures

Name	Time	Method
Composite of all-cause mortality and non-fatal myocardial infarction	1 Year

Trial Locations

Locations (1)

Amsterdam UMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands