Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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 7 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 at 3 years.

Official Title
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Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain

Conditions
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Chest Pain, Acute Coronary Syndrome, Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Coronary computed tomopraphic angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years. Within 24 hours from presenting to the ED with chest pain or other symptoms suggestive of coronary artery disease (CAD) HEART-score >3 (according to http://www.heartscore.nl/) Written informed consent obtained Exclusion Criteria: Any condition that may influence the patient's ability to comply with study protocol. Acute MI Known obstructive CAD (>50%) or previous PCI or CABG. Clear alternative diagnosis Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 Major allergy to iodinated contrast media Circumstances making high quality images unlikely. Not a Swedish resident with a personal ID-number. Pregnancy or breast feeding Further investigation for CAD not indicated, due to limited life expectancy, quality of life or functional status Previous inclusion in the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coronary computed tomopraphic angiography<br>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 7 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. | Diagnostic Test: Coronary computed tomopraphic angiography<br>* CCTA as soon as possible, preferably within 24 hours, but not later than within 7 days.<br>|
| No Intervention: No Coronary computed tomopraphic angiography<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | at 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or readmission because MI | death of any cause, readmission because of MI (I21) | 3 years | 
| Death | death of any cause | 3 years | 
| Cardiovascular death | death because of cardiovascular cause (I00-99) | 3 years | 
| MI (fatal or non-fatal) | readmission because of MI or death because of MI (I21) | 3 years | 
| Readmission because of unstable angina requiring revascularization | revascularization because of unstable angina not related to the index event. | 3 years | 
| Death, readmission because MI or stroke | death of any cause, readmission because of MI (I21) or stroke (I61-I64) | 3 years | 
| Stroke (fatal or non-fatal) | readmission because of stroke (I61-I64) or death because of stroke (I61-I64) | 3 years | 
| Resource use / Health care costs | Hospitalizations and investigations | 3 years | 
| Re-presentation to the ED because of chest pain | Re-presentation with chest pain as the main complaint | 3 years | 
| Invasive coronary angiography | Any invasive coronary angiography | 3 years | 
| Non-obstructive CAD at first invasive coronary angiography | Invasive coronary angiography without any significant stenoses | 3 years | 
| 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 |