Acute Coronary Syndrome, Chest Pain, Coronary Artery Disease
Conditions
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.
Interventions
DIAGNOSTIC_TESTCoronary computed tomopraphic angiography
CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Before adjudication, all documents will be masked regarding previous coronary computed tomographic angiography.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The composite of death, readmission because of MI or unstable angina requiring revascularization | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | through study completion, an average of 5 year | death of any cause |
| Cardiovascular death | through study completion, an average of 5 year | death because of cardiovascular cause (I00-99) |
| MI (fatal or non-fatal) | through study completion, an average of 5 year | readmission because of MI or death because of MI (I21) |
| Readmission because of unstable angina requiring revascularization | through study completion, an average of 5 year | revascularization because of unstable angina not related to the index event. |
| Death, readmission because MI or stroke | through study completion, an average of 5 year | death of any cause, readmission because of MI (I21) or stroke (I61-I64) |
| Stroke (fatal or non-fatal) | through study completion, an average of 5 year | readmission because of stroke (I61-I64) or death because of stroke (I61-I64) |
| Death or readmission because MI | through study completion, an average of 5 year | death of any cause, readmission because of MI (I21) |
| Re-presentation to the ED because of chest pain | through study completion, an average of 5 year | Re-presentation with chest pain as the main complaint |
| Invasive coronary angiography | through study completion, an average of 5 year | Any invasive coronary angiography |
| Non-obstructive CAD at first invasive coronary angiography | through study completion, an average of 5 year | Invasive coronary angiography without any significant stenoses |
| Angina | 1 year | at least grade 1 according to Rose questionnaire |
| Use of prevention medications | 1, 2 and 3 years | Use (dispensed prescriptions) of prevention medications (antiplatelet therapy, Statins, blood pressure lowering therapy) |
| Health-related quality of life | 1 year | RAND-36: 8 domains/scales |
| Resource use / Health care costs | through study completion, an average of 5 year | Hospitalizations and investigations |
Countries
Sweden
Contacts
Primary ContactLiselotte Persson, RN
Backup ContactHenrik Löfmark, MD
Outcome results
None listed