Actively Recruiting
Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain
Led by Karolinska Institutet · Updated on 2024-08-20
1600
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a diagnostic strategy using early coronary computed tomographic angiography (CCTA) in patients at intermediate risk who come to the Emergency Department with chest pain or symptoms suggestive of acute coronary syndrome but without acute myocardial infarction. The goal is to see if including early CCTA reduces the combined risk of death, hospital readmission for myocardial infarction, or unstable angina needing revascularization. Participants are randomly assigned to one of two groups: one group receives standard care plus early CCTA as soon as possible, preferably within 24 hours but no later than 21 days, using local CT scanning protocols. The other group receives standard care without early CCTA but may undergo other non-invasive functional tests like Exercise-ECG or stress echocardiography according to usual practice. All patients receive prevention treatments based on current guidelines if their examinations indicate coronary artery disease. During the study, patients will be monitored for the primary outcome, which is a combination of death, readmission for myocardial infarction, or unstable angina requiring revascularization, over an average follow-up of five years. Secondary outcomes include various cardiovascular events, health-related quality of life, and healthcare resource use. The study involves regular assessments and the responsible physician plans ongoing care based on diagnostic results and clinical findings.
CONDITIONS
Brief Title
Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Presenting within 24 hours to the Emergency Department with chest pain or symptoms suggestive of coronary artery disease
- HEART-score greater than 3
- Written informed consent obtained
You will not qualify if you...
- Any condition affecting ability to follow the study protocol
- Acute myocardial infarction
- Known obstructive coronary artery disease greater than 50% or previous PCI or CABG
- Clear alternative diagnosis for symptoms
- Estimated glomerular filtration rate below 30 ml/min/1.73m2
- Major allergy to iodinated contrast media
- Factors making high quality imaging unlikely
- Not a Swedish resident with a personal ID-number
- Pregnancy or breastfeeding
- Further CAD investigation not indicated due to limited life expectancy, quality of life, or functional status
- Previous inclusion in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 weeks
Participants are randomized to either an early Coronary Computed Tomographic Angiography (CCTA) performed as soon as possible within 21 days or to a strategy without early CCTA involving other diagnostic tests according to local routines.
1 visit for CCTA (in-person) or other diagnostic tests depending on strategy
Duration - Approximately 5 years
Participants are followed for an average of 5 years to monitor for clinical outcomes such as death, myocardial infarction, unstable angina requiring revascularization, and other cardiovascular events.
Follow-up visits as per standard care and study schedule
Trial Site Locations
Total: 1 location
1
Danderyd Hospital
Stockholm, Sweden, 18288
Actively Recruiting
Research Team
L
Liselotte Persson, RN
H
Henrik Löfmark, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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