Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary computed tomopraphic angiography.
- Who it may be relevant to
- Registry conditions: Chest Pain, Acute Coronary Syndrome, Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain
Overview
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 test Coronary computed tomopraphic angiography
CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days.
Primary outcome measures
- The composite of death, readmission because of MI or unstable angina requiring revascularization [Time frame: through study completion, an average of 5 year]
Secondary outcome measures (12)
- Death or readmission because MI [Time frame: through study completion, an average of 5 year]
- Death [Time frame: through study completion, an average of 5 year]
- Cardiovascular death [Time frame: through study completion, an average of 5 year]
- MI (fatal or non-fatal) [Time frame: through study completion, an average of 5 year]
- Readmission because of unstable angina requiring revascularization [Time frame: through study completion, an average of 5 year]
- Death, readmission because MI or stroke [Time frame: through study completion, an average of 5 year]
- Stroke (fatal or non-fatal) [Time frame: through study completion, an average of 5 year]
- Resource use / Health care costs [Time frame: through study completion, an average of 5 year]
- Re-presentation to the ED because of chest pain [Time frame: through study completion, an average of 5 year]
- Invasive coronary angiography [Time frame: through study completion, an average of 5 year]
- Non-obstructive CAD at first invasive coronary angiography [Time frame: through study completion, an average of 5 year]
- Angina [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Sweden · 1 center
- Danderyd Hospital — Stockholm
Identifiers
NCT: NCT04748237 · KIDS2020-1