CT Coronary Angiography for Type 2 Myocardial Infarction

NHS Trust

Status: Enrolling

Conditions: Coronary Artery Disease; Myocardial Infarction

Treatments: Diagnostic Test: CT coronary angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT06047392

GN22CA430

Details and patient eligibility

About

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.

Full 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)'.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Usual Care

No Intervention group

CT coronary angiography + usual care

Active Comparator group

Treatment:

Diagnostic Test: CT coronary angiography