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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
1,600
CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days.
Danderyd Hospital
Stockholm, Sweden
RECRUITINGThe composite of death, readmission because of MI or unstable angina requiring revascularization
death of any cause, readmission because of MI (I21) or revascularization because of unstable angina not related to the index event
Time frame: through study completion, an average of 5 year
Death or readmission because MI
death of any cause, readmission because of MI (I21)
Time frame: through study completion, an average of 5 year
Death
death of any cause
Time frame: through study completion, an average of 5 year
Cardiovascular death
death because of cardiovascular cause (I00-99)
Time frame: through study completion, an average of 5 year
MI (fatal or non-fatal)
readmission because of MI or death because of MI (I21)
Time frame: through study completion, an average of 5 year
Readmission because of unstable angina requiring revascularization
revascularization because of unstable angina not related to the index event.
Time frame: through study completion, an average of 5 year
Death, readmission because MI or stroke
death of any cause, readmission because of MI (I21) or stroke (I61-I64)
Time frame: through study completion, an average of 5 year
Stroke (fatal or non-fatal)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
readmission because of stroke (I61-I64) or death because of stroke (I61-I64)
Time frame: through study completion, an average of 5 year
Resource use / Health care costs
Hospitalizations and investigations
Time frame: through study completion, an average of 5 year
Re-presentation to the ED because of chest pain
Re-presentation with chest pain as the main complaint
Time frame: through study completion, an average of 5 year
Invasive coronary angiography
Any invasive coronary angiography
Time frame: through study completion, an average of 5 year
Non-obstructive CAD at first invasive coronary angiography
Invasive coronary angiography without any significant stenoses
Time frame: through study completion, an average of 5 year
Angina
at least grade 1 according to Rose questionnaire
Time frame: 1 year
Use of prevention medications
Use (dispensed prescriptions) of prevention medications (antiplatelet therapy, Statins, blood pressure lowering therapy)
Time frame: 1, 2 and 3 years
Health-related quality of life
RAND-36: 8 domains/scales
Time frame: 1 year