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

NCT05344612 | Recruiting

• 1 other identifier: NL81264.018.22
• Study Type: interventional
• Target: 6,444
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain; CAD

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause mortality and non-fatal myocardial infarction

  1 Year

Study Arms (2)

CTCA

EXPERIMENTAL

Radiation: CT Coronary Angiography

Standard care

NO INTERVENTION

Interventions

CT Coronary Angiography RADIATION

Upfront ct-coronary angiography

CTCA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 25, 2022
• Study Start: September 14, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

NL (1)