Clinical trial NCT04748237: Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients
Official title: Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chest Pain
Acute Coronary Syndrome
Coronary Artery Disease
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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 coronary computed tomographic angiography or not.
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The composite of death, readmission because of MI or unstable angina requiring revascularization
timeFrame: through study completion, an average of 5 year
Secondary outcomes:
measure: Death or readmission because MI
timeFrame: through study completion, an average of 5 year
measure: Death
timeFrame: through study completion, an average of 5 year
measure: Cardiovascular death
timeFrame: through study completion, an average of 5 year
measure: MI (fatal or non-fatal)
timeFrame: through study completion, an average of 5 year
measure: Readmission because of unstable angina requiring revascularization
timeFrame: through study completion, an average of 5 year
measure: Death, readmission because MI or stroke
timeFrame: through study completion, an average of 5 year
measure: Stroke (fatal or non-fatal)
timeFrame: through study completion, an average of 5 year
measure: Resource use / Health care costs
timeFrame: through study completion, an average of 5 year
measure: Re-presentation to the ED because of chest pain
timeFrame: through study completion, an average of 5 year
measure: Invasive coronary angiography
timeFrame: through study completion, an average of 5 year
measure: Non-obstructive CAD at first invasive coronary angiography
timeFrame: through study completion, an average of 5 year
measure: Angina
timeFrame: 1 year
measure: Use of prevention medications
timeFrame: 1, 2 and 3 years
measure: Health-related quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital
Study officials:
affiliation: Karolinska Institutet
name: Tomas Jernberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: