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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary computed tomopraphic angiography | Experimental | 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. |
|
| No Coronary computed tomopraphic angiography | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary computed tomopraphic angiography | Diagnostic Test | CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The 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 | through study completion, an average of 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Death or readmission because MI | death of any cause, readmission because of MI (I21) | through study completion, an average of 5 year |
| Death | death of any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liselotte Persson, RN | Contact | +46812355000 | Liselotte.Persson@sll.se | |
| Henrik Löfmark, MD | Contact | Henrik.Lofmark@sll.se |
| Name | Affiliation | Role |
|---|---|---|
| Tomas Jernberg, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danderyd Hospital | Recruiting | Stockholm | 18288 | Sweden |
Other researchers can, after completion of study and the first report, apply for making analyses in collaboration with the steering group.
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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Before adjudication, all documents will be masked regarding previous coronary computed tomographic angiography.
| through study completion, an average of 5 year |
| Cardiovascular death | death because of cardiovascular cause (I00-99) | through study completion, an average of 5 year |
| MI (fatal or non-fatal) | readmission because of MI or death because of MI (I21) | 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. | 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) | through study completion, an average of 5 year |
| Stroke (fatal or non-fatal) | readmission because of stroke (I61-I64) or death because of stroke (I61-I64) | through study completion, an average of 5 year |
| Resource use / Health care costs | Hospitalizations and investigations | 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 | through study completion, an average of 5 year |
| Invasive coronary angiography | Any invasive coronary angiography | through study completion, an average of 5 year |
| Non-obstructive CAD at first invasive coronary angiography | Invasive coronary angiography without any significant stenoses | through study completion, an average of 5 year |
| Angina | at least grade 1 according to Rose questionnaire | 1 year |
| Use of prevention medications | Use (dispensed prescriptions) of prevention medications (antiplatelet therapy, Statins, blood pressure lowering therapy) | 1, 2 and 3 years |
| Health-related quality of life | RAND-36: 8 domains/scales | 1 year |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |