Targeting Investigation and Treatment in Patients With Type 2 Myocardial Infarction (TARGET-Type 2): A Pilot Randomised Controlled Trial

AC22023

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.

2022-11-14

2024-06-30

2024-06-30

Active (not recruiting)

60

Inclusion Criteria: Adult patients with a clinical diagnosis of type 2 myocardial infarction, defined as: i. Symptoms of myocardial ischaemia, or signs of myocardial ischaemia on 12-lead electrocardiogram (≥0.5mm ST segment depression in any two contiguous leads or new regional T wave inversion) ii. A clinically significant change in high-sensitivity cardiac troponin concentration with at least one value above the 99th centile upper reference limit, or a single measurement if considered significantly elevated iii. Documented evidence of myocardial oxygen supply (anaemia, hypoxia, hypotension, bradycardia, tachycardia, arrhythmia) or demand (hypertension, left ventricular hypertrophy, valvular heart disease) imbalance. Exclusion Criteria: i. Patients under 30 years who are less likely to benefit from cardiac imaging ii. Inability to give informed consent iii. Patients on renal replacement therapy or with eGFR \<30ml/min iv. Patients with advanced frailty (based on Clinical Frailty Score ≥7) v. Patients who are pregnant or breast feeding vi. Patients with ST-segment elevation on 12-lead electrocardiogram vii. Patients with a clinical diagnosis of type 1 myocardial infarction viii. Patients who have had diagnostic imaging confirming coronary vasospasm, embolism or spontaneous coronary artery dissection has caused type 2 myocardial infarction ix. Previous randomization into TARGET-Type 2 pilot study

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2024-06-10