CT Coronary Angiography for Type 2 Myocardial Infarction

NCT ID: NCT06047392

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2025-02-28

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)'.

Conditions

Myocardial Infarction; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

CT coronary angiography + usual care

Group Type: ACTIVE_COMPARATOR

CT coronary angiography

Intervention Type: DIAGNOSTIC_TEST

Patients will undergo a CTCA according to local, standard protocol.

Interventions

CT coronary angiography

Patients will undergo a CTCA according to local, standard protocol.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

British Heart Foundation

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Good, MD

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Locations

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Maureen Travers

Role: CONTACT

maureen.travers@ggc.scot.nhs.uk

+44141 314 4012

References

Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J Acute Cardiovasc Care. 2024 Feb 9;13(1):55-161. doi: 10.1093/ehjacc/zuad107. No abstract available.

Reference Type: BACKGROUND

PMID: 37740496 (View on PubMed)

Other Identifiers

GN22CA430

Identifier Type: -

Identifier Source: org_study_id