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

Chest Pain Clinical Trial

— CLEAR-CAD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05344612
• Other study ID #: NL81264.018.22
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• CAD
• Chest Pain

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