Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients

NCT ID: NCT04748237

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-21
• Study Completion Date: 2025-12-31

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.

Conditions

Chest Pain; Acute Coronary Syndrome; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Coronary computed tomopraphic angiography

Intervention Type: DIAGNOSTIC_TEST

CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Coronary computed tomopraphic angiography

CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Dr. Tomas Jernberg

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomas Jernberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Danderyd Hospital

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Liselotte Persson, RN

Role: CONTACT

Liselotte.Persson@sll.se

+46812355000

Henrik Löfmark, MD

Role: CONTACT

Henrik.Lofmark@sll.se

Facility Contacts

Henrik Löfmark, MD

Role: primary

henrik.lofmark@sll.se

Liselotte Persson, RN

Role: backup

liselotte.persson@sll.se

Other Identifiers

KIDS2020-1

Identifier Type: -

Identifier Source: org_study_id