Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients

Not Applicable

Recruiting

• Conditions: Acute Coronary Syndrome; Chest Pain; Coronary Artery Disease
• Interventions: Diagnostic Test: Coronary computed tomopraphic angiography

• Registration Number: NCT04748237
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-01-21
• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-07
• Study First Posted: 2021-02-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-18
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

1. Age≥18 years.
2. Within 24 hours from presenting to the ED with chest pain or other symptoms suggestive of coronary artery disease (CAD)
3. HEART-score >3 (according to http://www.heartscore.nl/)
4. Written informed consent obtained

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Exclusion Criteria

1. Any condition that may influence the patient's ability to comply with study protocol.
2. Acute MI
3. Known obstructive CAD (>50%) or previous PCI or CABG.
4. Clear alternative diagnosis
5. Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
6. Major allergy to iodinated contrast media
7. Circumstances making high quality images unlikely.
8. Not a Swedish resident with a personal ID-number.
9. Pregnancy or breast feeding
10. Further investigation for CAD not indicated, due to limited life expectancy, quality of life or functional status
11. Previous inclusion in the trial

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coronary computed tomopraphic angiography	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.

Primary Outcome Measures

Name	Time	Method
The composite of death, readmission because of MI or unstable angina requiring revascularization	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 Outcome Measures

Name	Time	Method
Health-related quality of life	1 year	RAND-36: 8 domains/scales
Death or readmission because MI	through study completion, an average of 5 year	death of any cause, readmission because of MI (I21)
Death	through study completion, an average of 5 year	death of any cause
Resource use / Health care costs	through study completion, an average of 5 year	Hospitalizations and investigations
Non-obstructive CAD at first invasive coronary angiography	through study completion, an average of 5 year	Invasive coronary angiography without any significant stenoses
Angina	1 year	at least grade 1 according to Rose questionnaire
Cardiovascular death	through study completion, an average of 5 year	death because of cardiovascular cause (I00-99)
Death, readmission because MI or stroke	through study completion, an average of 5 year	death of any cause, readmission because of MI (I21) or stroke (I61-I64)
Invasive coronary angiography	through study completion, an average of 5 year	Any invasive coronary angiography
Use of prevention medications	1, 2 and 3 years	Use (dispensed prescriptions) of prevention medications (antiplatelet therapy, Statins, blood pressure lowering therapy)
Stroke (fatal or non-fatal)	through study completion, an average of 5 year	readmission because of stroke (I61-I64) or death because of stroke (I61-I64)
MI (fatal or non-fatal)	through study completion, an average of 5 year	readmission because of MI or death because of MI (I21)
Readmission because of unstable angina requiring revascularization	through study completion, an average of 5 year	revascularization because of unstable angina not related to the index event.
Re-presentation to the ED because of chest pain	through study completion, an average of 5 year	Re-presentation with chest pain as the main complaint

Trial Locations

Locations (1)

Danderyd Hospital; 🇸🇪 Stockholm, Sweden