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Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

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 7 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 at 3 years.

Eligibility

Inclusion Criteria:

  1. Age≄18 years.
  2. Within 24 hours from presenting to the ED with chest pain or other symptoms suggestive of coronary artery disease (CAD)
  3. HEART-score >3 (according to http://www.heartscore.nl/)
  4. Written informed consent obtained

Exclusion Criteria:

  1. Any condition that may influence the patient's ability to comply with study protocol.
  2. Acute MI
  3. Known obstructive CAD (>50%) or previous PCI or CABG.
  4. Clear alternative diagnosis
  5. Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
  6. Major allergy to iodinated contrast media
  7. Circumstances making high quality images unlikely.
  8. Not a Swedish resident with a personal ID-number.
  9. Pregnancy or breast feeding
  10. Further investigation for CAD not indicated, due to limited life expectancy, quality of life or functional status
  11. Previous inclusion in the trial

Study details

Chest Pain, Acute Coronary Syndrome, Coronary Artery Disease

NCT04748237

Karolinska Institutet

25 January 2024

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