Determining the Mechanism of Myocardial Injury and Role of Coronary Disease in Type 2 Myocardial Infarction (DEMAND-MI)
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|ClinicalTrials.gov Identifier: NCT03338504|
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : November 20, 2018
|Condition or disease||Intervention/treatment|
|Myocardial Infarction, Acute Myocardial Ischemia Myocardial Injury||Diagnostic Test: Invasive coronary angiography Radiation: CT coronary angiography Diagnostic Test: Cardiac MRI|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Determining the Mechanism of Myocardial Injury and Role of Coronary Disease in Type 2 Myocardial Infarction|
|Actual Study Start Date :||October 23, 2017|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
Suspected type 2 myocardial infarction
The investigators will identify consecutive patients with acute myocardial injury (defined as a rise and or fall in cardiac troponin concentration on serial testing, with at least one value >99th centile) where the likely mechanism of injury is thought to be myocardial oxygen supply and demand imbalance (e.g secondary to hypoxia, hypotension, tachycardia or anaemia). Patients will be identified through screening of cardiac troponin measurements. Patients who meet both the inclusion and exclusion criteria, will be approached and those who provide consent will comprise the study population. All patients will have a Cardiac MRI scan, with invasive coronary angiography or CT coronary angiography dependent on baseline fitness. The investigators will record demographic and clinical information from the electronic patient record for patients who meet inclusion criteria but have one or more exclusion criteria.
Diagnostic Test: Invasive coronary angiography
Where patients are fit, coronary angiography will be performed via the femoral or radial artery with 6F arterial catheters. In patients with one or more stenoses in a major epicardial vessel, a coronary pressure guidewire (PressureWire™ Aeris™, St. Jude Medical, St. Paul, Minnesota) will be used to determine distal coronary pressure and the fractional flow reserve (FFR) calculated at maximal adenosine-induced (intravenous 140 μg/kg/min) hyperaemia. Optical coherence tomography (OCT) will be performed in all three coronary vessels using a Dragonfly® coronary imaging catheter (Abbott Diagnostics, Abbott Park, Illinois) with pullback at 20 mm/s to identify features consistent with vulnerable plaque or recent plaque rupture.(16) If there is evidence of inducible myocardial ischaemia due to coronary artery stenosis, revascularisation with percutaneous coronary intervention may be considered if in the patients best interests.
Radiation: CT coronary angiography
CT coronary angiography will be performed using a 128 multidetector row CT. Patients with a heart rate exceeding 65 beats/min will receive oral beta-blockade 1 hour before computed tomography. Additional intravenous beta blockers will be given depending on heart rate at the time of imaging. All patients will receive sublingual glyceryl trinitrate (300 μg) immediately prior to dual cardiac and respiratory-gated computed tomography imaging of the coronary arteries. The investigators will quantify total plaque burden using CT calcium scoring. A bolus of 80-100 mL of contrast will be injected intravenously at 5 mL/s. An assessment of the functional consequences of coronary artery stenosis will be made using the computed tomography fractional flow reserve (CT-FFR) technique, using the HeartFlow platform.
Diagnostic Test: Cardiac MRI
Cardiovascular magnetic resonance (CMR) will be performed using a 3T scanner. The MRI scan will consist of localisers, axial and coronal HASTE images, standard breath-held and ECG-gated cine sequences. Short-axis cine images will be obtained for the assessment of left ventricle function and volumes. Left ventricle volumes, mass and ejection fraction will be assessed using dedicated software and values indexed to body surface area. Breath-held, ECG-gated T2 mapping sequences of the myocardium will be performed in the short-axis as a marker of myocardial inflammation. T1-weighted imaging of the coronary arteries will be performed to look for evidence of recent intraplaque thrombus or haemorrhage. The late gadolinium enhancement and T2 mapping techniques will identify regions of new or old myocardial infarction as well as other patterns of injury. Where there are no contraindications, stress MRI will be performed using intravenous Regadenoson.
- Prevalence of coronary disease [ Time Frame: 30 days of index presentation ]>50% stenosis in one or more epicardial vessels
- Lesion severity [ Time Frame: 30 days of index presentation ]Assessed using the invasive (FFR) or non-invasive (CT-FFR) fractional flow reserve technique
- Presence of intraluminal plaque rupture [ Time Frame: 30 days of index presentation ]Determined using invasive optical coherence tomography
- Pattern of myocardial injury [ Time Frame: 30 days of index presentation ]Determined using the late gadolinium enhancement technique
- Cardiovascular death and future myocardial infarction [ Time Frame: 1 year ]We will determine prevalence of major adverse cardiovascular events at one year in the study population, and those screened but not eligible for recruitment, to ensure a representative cohort.
- All cause mortality [ Time Frame: 1 year ]We will determine prevalence of major adverse cardiovascular events at one year in the study population, and those screened but not eligible for recruitment, to ensure a representative cohort.
Biospecimen Retention: Samples With DNA
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): NCT03338504
|Contact: Andrew R Chapman, MBChBemail@example.com|
|Centre for Cardiovascular Science||Recruiting|
|Edinburgh, United Kingdom, EH16 4SB|
|Contact: Andrew R Chapman, MBChB 01313153987 firstname.lastname@example.org|
|Principal Investigator: Andrew R Chapman, MD|
|Sub-Investigator: Nicholas L MIlls, MD PhD|
|Sub-Investigator: David E Newby, MD PhD|