CT Coronary Angiography for Type 2 Myocardial Infarction

Coronary Artery Disease Clinical Trial

Official title:

A Pilot Clinical Trial of CT Coronary Angiography for Patients With Suspected Type 2 Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047392
• Other study ID #: GN22CA430
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: February 2025

Study information

• Verified date: September 2023
• Source: NHS Greater Glasgow and Clyde
• Contact: Maureen Travers
• Phone: +44141 314 4012
• Email: maureen.travers[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)'.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Diagnostic Test:
• CT coronary angiography
Patients will undergo a CTCA according to local, standard protocol.

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth University Hospital	Glasgow

Sponsors (3)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	British Heart Foundation, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. 2023 Sep 22:zuad107. doi: 10.1093/ehjacc/zuad107. Online ahead of print. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in primary diagnosis	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.	At discharge from recruiting hospital (assessed up to day 30)
Secondary	Rate of invasive coronary angiography	Patients undergoing invasive coronary angiography following presentation	3 months
Secondary	Major adverse cardiovascular events	Myocardial infarction, stroke or death	12 months
Secondary	Rate of coronary revascularisation	Either percutaneous coronary intervention or coronary artery bypass grafting	12 months
Secondary	Rate of hospital readmission	Readmission to hospital for any reason	12 months
Secondary	Rate of additional cardiovascular investigations	Referral to outpatient clinic or for additional cardiovascular test (including exercise tolerance testing, echocardiography, myocardial perfusion imaging, cardiac MRI)	12 months
Secondary	Health related quality of life assessment	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.	6 months
Secondary	Functional assessment	Duke Activity Status Index (DASI). Range 0 - 58.2. Higher score indicates better functional status.	6 months
Secondary	Estimated cost of health care	Health care resource utilisation including length of hospital stay, investigations and treatment	12 months