Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients

Coronary Artery Disease Clinical Trial

— FAST-CCTA  

Official title:

Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748237
• Other study ID #: KIDS2020-1
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: Liselotte Persson, RN
• Phone: +46812355000
• Email: Liselotte.Persson[@]sll.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 7 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 at 3 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Coronary Artery Disease

Intervention

Diagnostic Test:
• Coronary computed tomopraphic angiography
CCTA as soon as possible, preferably within 24 hours, but not later than within 7 days.

Locations

Country	Name	City	State
Sweden	Danderyd Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

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