NCT05419583Completed
Targeting Investigation and Treatment in Patients With Type 2 Myocardial Infarction
Targeting Investigation and Treatment in Patients With Type 2 Myocardial Infarction (TARGET-Type 2): A Pilot Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 3 Jun 2022
- Start date
- 14 Nov 2022
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- University of Edinburgh
- Diseases
- Coronary artery disease
- NCT number
- NCT05419583
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 14 Nov 2022 to the primary completion date, 30 Jun 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous randomization into TARGET-Type 2 pilot study
Other illness
- Patients under 30 years who are less likely to benefit from cardiac imaging
- Patients with a clinical diagnosis of type 1 myocardial infarction
- Patients who have had diagnostic imaging confirming coronary vasospasm, embolism or spontaneous coronary artery dissection has caused type 2 myocardial infarction
Lab values
- Patients on renal replacement therapy or with eGFR \<30ml/min
Other
- Inability to give informed consent
- Patients with advanced frailty (based on Clinical Frailty Score ≥7)
- Patients who are pregnant or breast feeding
- Patients with ST-segment elevation on 12-lead electrocardiogram
Who the study is looking for
- Adult patients with a clinical diagnosis of type 2 myocardial infarction, defined as:
- 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)
- 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
- Documented evidence of myocardial oxygen supply (anaemia, hypoxia, hypotension, bradycardia, tachycardia, arrhythmia) or demand (hypertension, left ventricular hypertrophy, valvular heart disease) imbalance.
Age in the registry: 30 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NHS Lothian Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Victoria Hospital Coordinator of this site? Confirm its status | Kirkcaldy | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.