Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 1,600
- Locations
- 1
- Primary Endpoint
- The composite of death, readmission because of MI or unstable angina requiring revascularization
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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
Arms & Interventions
Coronary computed tomopraphic angiography
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.
Intervention: Coronary computed tomopraphic angiography (Diagnostic Test)
No Coronary computed tomopraphic angiography
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.
Outcomes
Primary Outcomes
The composite of death, readmission because of MI or unstable angina requiring revascularization
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
Secondary Outcomes
- Death(through study completion, an average of 5 year)
- Resource use / Health care costs(through study completion, an average of 5 year)
- Non-obstructive CAD at first invasive coronary angiography(through study completion, an average of 5 year)
- Death or readmission because MI(through study completion, an average of 5 year)
- Angina(1 year)
- Cardiovascular death(through study completion, an average of 5 year)
- Death, readmission because MI or stroke(through study completion, an average of 5 year)
- Invasive coronary angiography(through study completion, an average of 5 year)
- Use of prevention medications(1, 2 and 3 years)
- Stroke (fatal or non-fatal)(through study completion, an average of 5 year)
- Health-related quality of life(1 year)
- MI (fatal or non-fatal)(through study completion, an average of 5 year)
- Readmission because of unstable angina requiring revascularization(through study completion, an average of 5 year)
- Re-presentation to the ED because of chest pain(through study completion, an average of 5 year)
Investigators
Dr. Tomas Jernberg
Principal Investigator, Clinical Professor
Karolinska Institutet