Targeting Investigation and Treatment in Patients With Type 2 Myocardial Infarction (TARGET-Type 2)
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ClinicalTrials.gov Identifier: NCT05419583 |
Recruitment Status :
Recruiting
First Posted : June 15, 2022
Last Update Posted : August 22, 2023
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Condition or disease | Intervention/treatment | Phase |
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Myocardial Infarction Type 2 | 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) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Targeting Investigation and Treatment in Patients With Type 2 Myocardial Infarction (TARGET-Type 2): A Pilot Randomised Controlled Trial |
Actual Study Start Date : | November 14, 2022 |
Estimated Primary Completion Date : | November 30, 2023 |
Estimated Study Completion Date : | November 30, 2023 |
Arm | Intervention/treatment |
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No Intervention: Standard care
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.
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Experimental: Complex intervention
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.
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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 |
- Trial process outcomes: eligibility, approach, consent and randomisation [ Time Frame: 90 days ]The proportion of patients who are eligible, approached, consented and randomised
- Recruitment rate [ Time Frame: 30 days and 90 days ]Rate per month and overall
- Adherence to recommended investigation [ Time Frame: 90 days ]Determined as the proportion of patients who received recommended investigation
- Adherence to recommended treatment [ Time Frame: 90 days ]Determined as the proportion of patients who received recommended treatment
- Proportion of patients with changes in prescription of secondary prevention therapy [ Time Frame: 90 days ]Defined as initiation, intensification or cessation of cardiac medication including aspirin, clopidogrel, statin, bisoprolol or ACE-inhibitor and others as defined in data dictionary.
- Frequency of investigation and treatment [ Time Frame: 90 days ]Proportion of patients who undergo routine cardiac investigation (echocardiography, invasive coronary angiography, percutaneous coronary intervention, CT coronary angiography, cardiac MRI) in the standard care arm per month
- Change in classification of myocardial infarction [ Time Frame: 90 days ]Proportion of patients in whom the classification of myocardial infarction changes after study intervention
- Quantity of missing data [ Time Frame: Baseline and 90 days ]
- Rate of myocardial infarction [ Time Frame: 90 days ]As per the Fourth Universal Definition
- Rate of all-cause death [ Time Frame: 90 days ]
- Rate of cardiovascular death [ Time Frame: 90 days ]Defined as death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to haemorrhage, and death due to other cardiovascular causes
- Rate of cardiac death [ Time Frame: 90 days ]Defined as death resulting from an acute myocardial infarction, sudden cardiac death, or death due to heart failure.
- Rate of non-cardiovascular death [ Time Frame: 90 days ]Defined as death arising from any other cause not listed under cardiovascular death
- Rate of hospitalisation with heart failure [ Time Frame: 90 days ]
- Rate of unscheduled coronary revascularization [ Time Frame: 90 days ]
- Rate of major bleeding [ Time Frame: 90 days ]Bleeding Academic Research Consortium [BARC] 3-5
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Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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): NCT05419583
Contact: Andrew Chapman, MBChB PhD | 01315361000 | a.r.chapman@ed.ac.uk | |
Contact: Caelan Taggart, MBChB | 01315361000 | caelan.taggart@ed.ac.uk |
United Kingdom | |
Victoria Hospital | Recruiting |
Kirkcaldy, Fife, United Kingdom, KY25AH | |
Contact: Jagdeep Singh, MBChB 01592643355 jagdeep.singh@nhs.scot | |
NHS Lothian | Recruiting |
Edinburgh, Lothian, United Kingdom, EH16 4SB | |
Contact: Caelan Taggart, MBChB 01315361000 c.taggart@ed.ac.uk |
Study Chair: | Andrew Chapman, MBChB PhD | University of Edinburgh |
Responsible Party: | University of Edinburgh |
ClinicalTrials.gov Identifier: | NCT05419583 |
Other Study ID Numbers: |
AC22023 |
First Posted: | June 15, 2022 Key Record Dates |
Last Update Posted: | August 22, 2023 |
Last Verified: | May 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Requests for IPD will be considered on an individual basis in line with ethical and regulatory approvals |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Type 2 myocardial infarction Randomised controlled trial Fourth Universal Definition of Myocardial Infarction Coronary artery disease Left ventricular systolic dysfunction |
Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Aspirin Warfarin Apixaban Anticoagulants Edoxaban Platelet Aggregation Inhibitors |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |