Danderyd Hospital
Stockholm, 18288, Sweden
Location status: Recruiting
NCT Number: NCT04748237
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Stockholm, 18288, Sweden
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days.
Time frame: through study completion, an average of 5 year
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 of any cause, readmission because of MI (I21)
Time frame: through study completion, an average of 5 year
death of any cause
Time frame: through study completion, an average of 5 year
death because of cardiovascular cause (I00-99)
Time frame: through study completion, an average of 5 year
readmission because of MI or death because of MI (I21)
Time frame: through study completion, an average of 5 year
revascularization because of unstable angina not related to the index event.
Time frame: through study completion, an average of 5 year
death of any cause, readmission because of MI (I21) or stroke (I61-I64)
Time frame: through study completion, an average of 5 year
readmission because of stroke (I61-I64) or death because of stroke (I61-I64)
Time frame: through study completion, an average of 5 year
Hospitalizations and investigations
Time frame: through study completion, an average of 5 year
Re-presentation with chest pain as the main complaint
Time frame: through study completion, an average of 5 year
Any invasive coronary angiography
Time frame: through study completion, an average of 5 year
Invasive coronary angiography without any significant stenoses
Time frame: 1 year
at least grade 1 according to Rose questionnaire
Time frame: 1, 2 and 3 years
Use (dispensed prescriptions) of prevention medications (antiplatelet therapy, Statins, blood pressure lowering therapy)
Time frame: 1 year
RAND-36: 8 domains/scales
Contact information is provided by the study sponsor or research team.
Henrik Löfmark, MD
CONTACT
Liselotte Persson, RN
CONTACT
Karolinska Institutet
Other
Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain
Acronym: FAST-CCTA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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