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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Enrolling

Conditions: CAD; Chest Pain

Treatments: Radiation: CT Coronary Angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT05344612

NL81264.018.22

Details and patient eligibility

About

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.

Enrollment: 6,444 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

6,444 participants in 2 patient groups

CTCA

Experimental group

Treatment:

Radiation: CT Coronary Angiography

Standard care

No Intervention group