Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients (FAST-CCTA)

Karolinska Institute

Status: Enrolling

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Chest Pain

Treatments: Diagnostic Test: Coronary computed tomopraphic angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT04748237

KIDS2020-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,600 participants in 2 patient groups

Coronary computed tomopraphic angiography

Experimental group

Description:

Patients randomized to strategy including early CCTA will receive standard care according to responsible physician and referred to a CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days. Local scanning protocols can be used on ≥64-slice multi-detector CT scanners able to perform ECG-gated coronary angiography. The coronary angiography will be classified as normal (or near normal) or as having atherosclerosis (CAD). The report will also classify each vessel (left main, prox LAD, mid or distal LAD, LCX and RCA regarding degree of stenosis (no stenosis, 0-49%, ≥50%, or not possible to estimate because of calcification or technical reason). The result will be presented to the responsible physician as soon as possible and who will plan further care of the patients.

Treatment:

Diagnostic Test: Coronary computed tomopraphic angiography

No Coronary computed tomopraphic angiography

No Intervention group

Description:

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. Regardless of diagnostic strategy, the responsible physician is encouraged to initiate secondary prevention measures if the investigations indicate signs of CAD, including medication with aspirin and statins.