Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients (FAST-CCTA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Chest Pain; Acute Coronary Syndrome
• Intervention / Treatment: Diagnostic test: Coronary computed tomopraphic angiography

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 3500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liselotte Persson, RN; Phone Number: +46812355000; Email: Liselotte.Persson@sll.se
• Study Contact Backup: Name: Henrik Löfmark, MD; Email: henrik.lofmark@sll.se

Study Locations

• Sweden
  • Stockholm, Sweden, 18288
    • Recruiting
    • Danderyd hospital
    • Contact: Henrik Löfmark, MD; Email: henrik.lofmark@sll.se
    • Contact: Liselotte Persson, RN; Email: liselotte.persson@sll.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 7 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.	Diagnostic test: Coronary computed tomopraphic angiography; CCTA as soon as possible, preferably within 24 hours, but not later than within 7 days.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Tomas Jernberg, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 7, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Coronary Artery Disease; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: KIDS2020-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Other researchers can, after completion of study and the first report, apply for making analyses in collaboration with the steering group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No