Coronary Computed Tomography Versus Invasive Angiography for Non-ST Elevation Acute Coronary Syndrome

Ischemic Heart Disease Clinical Trial

— TRACTION  

Official title:

Team-based Interventional Triage in Acute Coronary Syndrome Based on Non-Invasive Computed Tomography Coronary Angiography - a Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101862
• Other study ID #: H-23024848
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2036

Study information

• Verified date: October 2023
• Source: Herlev and Gentofte Hospital
• Contact: Niels Thue Olsen, PhD
• Phone: +45 38 68 38 68
• Email: niels.thue.olsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Coronary computed tomography angiography (CCTA) is a widely accepted initial diagnostic test for individuals suspected of having chronic coronary syndromes. However, there is limited evidence supporting its use in the acute setting. So far, no large-scale randomized trial has examined the performance of CCTA as an alternative to invasive coronary angiography (ICA) in individuals with non-ST-segment elevation myocardial infarction (NSTEACS). If CCTA were to replace ICA as a routine procedure for individuals with NSTEACS, it could reduce the risk of complications related to ICA, improve patient comfort, expedite decision-making, and reduce healthcare expenses and interhospital transfers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: October 1, 2036
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Admitted with non-ST-segment elevation myocardial infarction or unstable angina pectoris and an indication for subacute ICA
• Elevated troponin or ischemic electrocardiographic changes
• Written informed consent

Exclusion criteria:

• Instability requiring acute or emergent ICA
• History of percutaneous coronary intervention or coronary artery bypass grafting
• Estimated glomerular filtration rate < 30 mL/min/1.73m2
• Expected poor quality of the CCTA
• Prior CCTA or ICA during index admission or within 1 week
• Known allergy to beta-blockers or contrast agent
• Pregnant or nursing
• Previously randomized in this trial

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina Pectoris, Unstable
• Angina, Unstable
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Non STEMI

Intervention

Procedure:
• CCTA
Participants will be examined during admission.
• Conventional ICA
Standard-of-care with conventional ICA.

Other:
• Team-based interventional triage
If the CCTA suggests a potential requirement for revascularization, the CCTA will be discussed at a coronary CT-team conference to establish the treatment strategy and provide guidance for any necessary interventional procedure.

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte Hospital	Copenhagen	Hellerup

Sponsors (7)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	Amager Hospital, Bispebjerg Hospital, Hvidovre University Hospital, North Zealand Hospital, Denmark, Rigshospitalet, Denmark, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a combined endpoint of major adverse cardiac events	All-cause mortality, non-fatal myocardial infarction, hospitalization with refractory angina, or hospitalization with heart failure.	At 1 year.
Secondary	Number of participants with a combined endpoint of major adverse cardiac events	All-cause mortality, non-fatal myocardial infarction, hospitalization with refractory angina, or hospitalization with heart failure.	At 1st hospital discharge, an average of 2 days, and at 30 days.
Secondary	Number of participants with all-cause mortality		At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year.
Secondary	Number of participants with non-fatal myocardial infarction		At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year.
Secondary	Number of participants with hospitalization with refractory angina		At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year.
Secondary	Number of participants with hospitalization with heart failure.		At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year.
Secondary	Number of participants with stroke		At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year.
Secondary	Number of participants with cardiovascular death		At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year.
Secondary	Number of participants with serious adverse events		At 1st hospital discharge, an average of 2 days.
Secondary	Number of participants with procedure-related complications		At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year.
Secondary	Number of participants with bleeding according to Bleeding Academic Research Consortium		At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year.
Secondary	Number of participants with coronary revascularization		At 1st hospital discharge, an average of 2 days, at 30 days, and at 1 year.
Secondary	Number of participants with hospitalization for any cardiac reason or related to cardiovascular treatment		At 1 year
Secondary	Number of participants with any invasive or non-invasive examination for ischemic heart disease		At 1st hospital discharge, an average of 2 day, and at 1 year.
Secondary	Costs of index admission, cardiovascular visits and admissions, and procedures		At 1 year.
Secondary	Angina symptom burden	Measured by Seattle Angina Questionnaire	At 1 year.
Secondary	Health-related Quality of life	Measured by EQ-5D-5L	At 1 year.
Secondary	Length of index hospitalization		At 1st hospital discharge, an average of 2 days.
Secondary	Time from index hospitalization to examination		At examination, an average of 1 day.
Secondary	Radiation dosage of all cardiac diagnostic examinations and interventions		At 1st hospital discharge, an average of 2 days, and at 1 year.
Secondary	Fluoroscopy time		At 1st hospital discharge, an average of 2 days.
Secondary	Procedure time		At 1st hospital discharge, an average of 2 days.
Secondary	Contrast use		At 1st hospital discharge, an average of 2 days.