Targeting Investigation and Treatment in Patients With Type 2 Myocardial Infarction

NCT05419583 | Completed

• 1 other identifier: AC22023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Type 2 myocardial infarction; Randomised controlled trial; Fourth Universal Definition of Myocardial Infarction; Coronary artery disease; Left ventricular systolic dysfunction

Outcome Measures

Primary Outcomes (1)

• Trial process outcomes: eligibility, approach, consent and randomisation

  The proportion of patients who are eligible, approached, consented and randomised

  90 days

Secondary Outcomes (7)

• Recruitment rate

  30 days and 90 days

• Adherence to recommended investigation

  90 days

• Adherence to recommended treatment

  90 days

• Proportion of patients with changes in prescription of secondary prevention therapy

  90 days

• Frequency of investigation and treatment

  90 days

Other Outcomes (8)

• Rate of myocardial infarction

  90 days

• Rate of all-cause death

  90 days

• Rate of cardiovascular death

  90 days

Study Arms (2)

Standard care

NO INTERVENTION

Patients will continue to be treated by the clinical team based on NHS guidelines. They will receive no additional visits from the study however may be asked to participate in qualitative interviews at the end of the study about their usual care. The standard care pathway may involve further investigation with clinically indicated tests or treatments and no appropriate tests or treatments will be withheld.

Complex intervention

EXPERIMENTAL

A structured risk assessment for coronary disease or left ventricular impairment and management plan delivered by a cardiologist to guide targeted investigation and treatment. This may include imaging with coronary computed tomography angiography (CCTA), invasive coronary angiography, transthoracic echocardiography or cardiac MRI. Treatments may include antiplatelet and anticoagulant therapy, statin therapy or treatments for heart failure as indicated in line with international guidelines.

Diagnostic Test: Coronary computed tomography angiography; Diagnostic Test: Invasive coronary angiography; Diagnostic Test: Transthoracic echocardiography; Diagnostic Test: Cardiac MRI scan; Drug: Antiplatelet Drug (Aspirin or Statin); Drug: Anticoagulants (Apixaban, Edoxaban, Rivaroxoban, Warfarin); Drug: Guideline directed heart failure therapy; Drug: Statins (Cardiovascular Agents)

Interventions

Coronary computed tomography angiography DIAGNOSTIC_TEST

CT scan of the heart arteries

Complex intervention

Invasive coronary angiography DIAGNOSTIC_TEST

Invasive coronary angiography via the radial or femoral approach

Complex intervention

Transthoracic echocardiography DIAGNOSTIC_TEST

Ultrasound scan of the heart

Complex intervention

Cardiac MRI scan DIAGNOSTIC_TEST

An MRI scan to assess the heart structure and function

Complex intervention

Antiplatelet Drug (Aspirin or Statin) DRUG

Antiplatelet therapy for coronary artery disease

Complex intervention

Anticoagulants (Apixaban, Edoxaban, Rivaroxoban, Warfarin) DRUG

Anticoagulant therapy if atrial fibrillation identified (DOAC or Warfarin)

Complex intervention

Guideline directed heart failure therapy DRUG

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)

Complex intervention

Statins (Cardiovascular Agents) DRUG

Statins will be recommended for patients with coronary plaque disease or hypercholesterolaemia

Complex intervention

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• Chief Scientist Office of the Scottish Government: collaborator

Study Sites (2)

Victoria Hospital

Kirkcaldy, Fife, KY25AH, United Kingdom

Location

NHS Lothian

Edinburgh, Lothian, EH16 4SB, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease; Ventricular Dysfunction, Left

Interventions

Echocardiography; Platelet Aggregation Inhibitors; Aspirin; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Anticoagulants; apixaban; edoxaban; Warfarin; Cardiovascular Agents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Andrew Chapman, MBChB PhD

  University of Edinburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 15, 2022
• Study Start: November 14, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

GB (2)