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CT Coronary Angiography for Type 2 Myocardial Infarction

Primary Purpose

Myocardial Infarction, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CT coronary angiography
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction focused on measuring Computed Tomography, Myocardial Infarction, Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with known or suspected Type 2 MI Exclusion Criteria: Unable to provide written informed consent Known severe coronary artery disease Previous PCI Previous CABG Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2 Tachycardia (>75bpm) refractory to heart rate control Pregnancy

Sites / Locations

  • Queen Elizabeth University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care

CT coronary angiography + usual care

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of invasive coronary angiography
Patients undergoing invasive coronary angiography following presentation
Major adverse cardiovascular events
Myocardial infarction, stroke or death
Rate of coronary revascularisation
Either percutaneous coronary intervention or coronary artery bypass grafting
Rate of hospital readmission
Readmission to hospital for any reason
Rate of additional cardiovascular investigations
Referral to outpatient clinic or for additional cardiovascular test (including exercise tolerance testing, echocardiography, myocardial perfusion imaging, cardiac MRI)
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.
Functional assessment
Duke Activity Status Index (DASI). Range 0 - 58.2. Higher score indicates better functional status.
Estimated cost of health care
Health care resource utilisation including length of hospital stay, investigations and treatment

Full Information

First Posted
August 2, 2023
Last Updated
September 26, 2023
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow, British Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT06047392
Brief Title
CT Coronary Angiography for Type 2 Myocardial Infarction
Official Title
A Pilot Clinical Trial of CT Coronary Angiography for Patients With Suspected Type 2 Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow, British Heart Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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)'.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Coronary Artery Disease
Keywords
Computed Tomography, Myocardial Infarction, Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Title
CT coronary angiography + usual care
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
CT coronary angiography
Intervention Description
Patients will undergo a CTCA according to local, standard protocol.
Primary Outcome Measure Information:
Title
Change in primary diagnosis
Description
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.
Time Frame
At discharge from recruiting hospital (assessed up to day 30)
Secondary Outcome Measure Information:
Title
Rate of invasive coronary angiography
Description
Patients undergoing invasive coronary angiography following presentation
Time Frame
3 months
Title
Major adverse cardiovascular events
Description
Myocardial infarction, stroke or death
Time Frame
12 months
Title
Rate of coronary revascularisation
Description
Either percutaneous coronary intervention or coronary artery bypass grafting
Time Frame
12 months
Title
Rate of hospital readmission
Description
Readmission to hospital for any reason
Time Frame
12 months
Title
Rate of additional cardiovascular investigations
Description
Referral to outpatient clinic or for additional cardiovascular test (including exercise tolerance testing, echocardiography, myocardial perfusion imaging, cardiac MRI)
Time Frame
12 months
Title
Health related quality of life assessment
Description
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.
Time Frame
6 months
Title
Functional assessment
Description
Duke Activity Status Index (DASI). Range 0 - 58.2. Higher score indicates better functional status.
Time Frame
6 months
Title
Estimated cost of health care
Description
Health care resource utilisation including length of hospital stay, investigations and treatment
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with known or suspected Type 2 MI Exclusion Criteria: Unable to provide written informed consent Known severe coronary artery disease Previous PCI Previous CABG Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2 Tachycardia (>75bpm) refractory to heart rate control Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maureen Travers
Phone
+44141 314 4012
Email
maureen.travers@ggc.scot.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Good, MD
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
37740496
Citation
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.
Results Reference
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CT Coronary Angiography for Type 2 Myocardial Infarction

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