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NCT Number: NCT05344612

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT coronary angiography

Radiation

Upfront ct-coronary angiography

Primary outcomes

  1. Composite of all-cause mortality and non-fatal myocardial infarction

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Acronym: CLEAR-CAD

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 25, 2022
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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