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CT Coronary Angiography for Type 2 Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT06047392
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 28, 2023
Sponsor:
Collaborators:
University of Glasgow
British Heart Foundation
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Coronary Artery Disease Diagnostic Test: CT coronary angiography Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Clinical Trial of CT Coronary Angiography for Patients With Suspected Type 2 Myocardial Infarction
Actual Study Start Date : July 24, 2023
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Usual Care
Active Comparator: CT coronary angiography + usual care Diagnostic Test: CT coronary angiography
Patients will undergo a CTCA according to local, standard protocol.


Outcome Measures
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Primary Outcome Measures :
  1. Change in primary diagnosis [ Time Frame: 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 :
  1. Rate of invasive coronary angiography [ Time Frame: 3 months ]
    Patients undergoing invasive coronary angiography following presentation

  2. Major adverse cardiovascular events [ Time Frame: 12 months ]
    Myocardial infarction, stroke or death

  3. Rate of coronary revascularisation [ Time Frame: 12 months ]
    Either percutaneous coronary intervention or coronary artery bypass grafting

  4. Rate of hospital readmission [ Time Frame: 12 months ]
    Readmission to hospital for any reason

  5. Rate of additional cardiovascular investigations [ Time Frame: 12 months ]
    Referral to outpatient clinic or for additional cardiovascular test (including exercise tolerance testing, echocardiography, myocardial perfusion imaging, cardiac MRI)

  6. Health related quality of life assessment [ Time Frame: 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.

  7. Functional assessment [ Time Frame: 6 months ]
    Duke Activity Status Index (DASI). Range 0 - 58.2. Higher score indicates better functional status.

  8. Estimated cost of health care [ Time Frame: 12 months ]
    Health care resource utilisation including length of hospital stay, investigations and treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06047392


Contacts
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Contact: Maureen Travers +44141 314 4012 maureen.travers@ggc.scot.nhs.uk

Locations
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United Kingdom
Queen Elizabeth University Hospital Recruiting
Glasgow, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
British Heart Foundation
Investigators
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Principal Investigator: Richard Good, MD NHS Greater Glasgow and Clyde
More Information
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Publications:

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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT06047392    
Other Study ID Numbers: GN22CA430
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by NHS Greater Glasgow and Clyde:
Computed Tomography
Myocardial Infarction
Coronary Artery Disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases