Targeting Investigation and Treatment in Patients With Type 2 Myocardial Infarction
NCT05419583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-09-19
Summary
Type 2 myocardial infarction (MI) is common and associated with poor clinical outcomes, with as many as one in ten experiencing recurrent MI within one year, and only one in three alive at five years. Recent prospective data demonstrates two-thirds of patients with type 2 MI have underlying coronary artery disease and one-third have left ventricular systolic impairment. Importantly, this is previously unrecognised in over half of all patients, suggesting there may be opportunities to identify and treat these underlying conditions to modify clinical outcomes. The investigators will undertake a pilot randomised controlled trial in which patients will be randomised to standard care or a complex intervention involving detailed cardiology assessment for the likelihood of coronary disease or left ventricular impairment, followed by targeted investigation and treatment where underlying disease is identified. This study will inform the design and delivery of a prospective multi-centre randomised controlled trial powered for clinical outcomes.
Conditions
- Myocardial Infarction Type 2
Interventions
- DIAGNOSTIC_TEST
-
Coronary computed tomography angiography
CT scan of the heart arteries
- DIAGNOSTIC_TEST
-
Invasive coronary angiography
Invasive coronary angiography via the radial or femoral approach
- DIAGNOSTIC_TEST
-
Transthoracic echocardiography
Ultrasound scan of the heart
- DIAGNOSTIC_TEST
-
Cardiac MRI scan
An MRI scan to assess the heart structure and function
- DRUG
-
Antiplatelet Drug (Aspirin or Statin)
Antiplatelet therapy for coronary artery disease
- DRUG
-
Anticoagulants (Apixaban, Edoxaban, Rivaroxoban, Warfarin)
Anticoagulant therapy if atrial fibrillation identified (DOAC or Warfarin)
- DRUG
-
Guideline directed heart failure therapy
Use of guideline approved heart failure treatments (ACE-inhibitor / angiotensin receptor blocker (ARB) / ARB and neprilysin inhibitor, mineralocorticoid receptor antagonist, beta blocker, SGLT-2 inhibitor, diuretic therapy)
- DRUG
-
Statins (Cardiovascular Agents)
Statins will be recommended for patients with coronary plaque disease or hypercholesterolaemia
Sponsors & Collaborators
-
Chief Scientist Office of the Scottish Government
collaborator OTHER_GOV -
University of Edinburgh
lead OTHER
Principal Investigators
-
Andrew Chapman, MBChB PhD · University of Edinburgh
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-11-14
- Primary Completion
- 2024-06-30
- Completion
- 2024-06-30
Countries
- United Kingdom
Study Locations
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