CT Coronary Angiography for Type 2 Myocardial Infarction

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Myocardial Infarction
• Interventions: Diagnostic Test: CT coronary angiography

• Registration Number: NCT06047392
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

This study is to explore whether a computed tomography (CT) scan of the heart arteries might improve the care of patients that have presented with a suspected Type 2 myocardial infarction (MI). The Investigators hope to demonstrate that these patients may be the ideal group of patients to benefit from cardiac CT scan imaging by; 1. confirming whether they have any disease in their heart arteries 2. demonstrating the severity of the heart artery disease 3. revealing an alternative cause for their presentation 4. avoiding the need for an invasive heart artery angiogram.

Detailed Description

An increasing number of patients present to hospital with a heart attack (myocardial infarction, MI). Heart attacks can be caused by instability and narrowing in heart arteries (Type 1 MI) or strain on the heart (Type 2 MI). Type 2 MIs can be the result of other problems with the heart including inflammation and rhythm problems or other conditions such as infection or low blood count. Both Type 1 and Type 2 MI patients have increased risk of further problems following this presentation. Deciding whether a patient has suffered a Type 1 MI or a Type 2 MI can be very difficult leaving uncertainty for patients and health care staff. Often patients with Type 2 myocardial infarction are either referred for an invasive coronary angiogram (a procedure where dye is injected into the heart arteries directly) or have no further investigations. Invasive angiograms carry a small risk of complications including heart attack, stroke and, rarely, death.

Cardiac CT scanning has emerged in the last 20 years as the first test usually performed to investigate patients that present with stable chest pain symptoms to the outpatient department. The role of cardiac CT in patients that present as an emergency with a suspected heart attack is not yet established.

To date, there are no substantive data on the role of computed tomography coronary angiography (CTCA) in patients with known or suspected Type 2 MI. A pilot study is proposed to address the information gaps. The specific areas of uncertainty include feasibility of enrolling into an imaging trial during acute medical care, feasibility of randomisation (including compliance and cross-overs), incremental diagnostic value, safety (procedure and post-procedure) and healthcare resource utilisation. The study aims to address the gap in evidence highlighted by the recent European Society of Cardiology Guidelines for the management of acute coronary syndromes, 'evaluating diagnostic strategies to better classify patients according to their type of MI (Type 1 vs Type 2)'.

Study Timeline

• Study Start: 2023-07-24
• Study First Submitted: 2023-08-02
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-21
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with known or suspected Type 2 MI

Exclusion Criteria

1. Unable to provide written informed consent
2. Known severe coronary artery disease
3. Previous PCI
4. Previous CABG
5. Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2
6. Tachycardia (>75bpm) refractory to heart rate control
7. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT coronary angiography + usual care	CT coronary angiography	-

Primary Outcome Measures

Name	Time	Method
Change in primary diagnosis	At discharge from recruiting hospital (assessed up to day 30)	The primary outcome is a change in the primary diagnosis defined as a difference in the final diagnosis at discharge compared to the initial diagnosis prior to study recruitment. The primary outcome will therefore take account of the diagnostic effect of CTCA and any changes that might normally occur during standard care.

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	12 months	Myocardial infarction, stroke or death
Rate of coronary revascularisation	12 months	Either percutaneous coronary intervention or coronary artery bypass grafting
Rate of hospital readmission	12 months	Readmission to hospital for any reason
Rate of additional cardiovascular investigations	12 months	Referral to outpatient clinic or for additional cardiovascular test (including exercise tolerance testing, echocardiography, myocardial perfusion imaging, cardiac MRI)
Rate of invasive coronary angiography	3 months	Patients undergoing invasive coronary angiography following presentation
Health related quality of life assessment	6 months	EQ-5D-5L questionnaire. Reported as 5 digit code (Range 11111 - 55555) with higher numbers indicating worse quality of life and EQ visual analogue scale (Range 0-100) with higher numbers indicating better quality of life.
Functional assessment	6 months	Duke Activity Status Index (DASI). Range 0 - 58.2. Higher score indicates better functional status.
Estimated cost of health care	12 months	Health care resource utilisation including length of hospital stay, investigations and treatment

Trial Locations

Locations (1)

Queen Elizabeth University Hospital; 🇬🇧 Glasgow, United Kingdom