NCT04748237

Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients

Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,600 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim is to determine whether a diagnostic strategy including early coronary computed tomographic angiography in intermediate-risk patients presenting to the Emergency Department with chest pain reduces the composite endpoint of death, readmission because of myocardial infarction or unstable angina requiring revascularization.

Detailed description

Patients presenting to the ED with chest pain or other symptoms suggestive of ACS, without acute MI but with an intermediate risk (HEART-score \>3) will after written informed consent be randomized to either a strategy with an initial CCTA or not. Patients randomized to strategy including early CCTA will receive standard care according to responsible physician and perform a CCTA as soon as possible (in most cases within 24 hours, but at least within 21 days).The result will be presented to the responsible physician who will plan further care of the patients. Patients randomized to a strategy not including early CCTA will receive further care (including examinations) according to responsible physician but not include early CCTA. These patients will often undergo a non-invasive functional test, such as Exercise-ECG, stress echocardiography or nuclear imaging according to local routines, but not always. All patients should receive optimal prevention according to current guidelines. The responsible physician will be encouraged to initiate secondary prevention measures if examinations show signs of CAD. The primary endpoint is composite of death, readmission because of MI or unstable angina requiring revascularization.

Conditions

• Chest Pain
• Acute Coronary Syndrome
• Coronary Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Coronary computed tomopraphic angiography	CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days.

Timeline

• Start date: 2021-01-21
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-02-10
• Last updated: 2024-08-20

Locations

1 site across 1 country: Sweden