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67 active trials for Myocardial Ischemia

PeRiOperaTivE CardioproTection With Ivabradine in Non-cardiac Surgery

Perioperative myocardial injury (PMI) after non-cardiac surgery (NCS), i.e. the elevation of postoperative troponin, occurs in nearly 20% of patients older than 45 years undergoing NCS and is independently and strongly associated with post-operative mortality (30-day mortality up to 10%). With over 300 million surgical interventions every year worldwide, PMI has a high clinical relevance on the health of the population. Heart rate (HR) is an independent and modifiable risk factor for PMI and death after non-cardiac surgery. Numerous studies showed that beta-blockers decrease myocardial ischemia after surgery in a heart-rate dependent manner, but this beneficial effect is surpassed by an increased incidence of perioperative hypotension and death. Currently, no single intervention is available to decrease the risk of perioperative cardiac complications. Ivabradine (IVA) is a negative chronotropic agent without significant effects on contractility or vascular tone and has been shown to improve outcomes in the setting of chronic and acute heart diseases. Rationale for pilot feasibility trial: the planned definitive large trial is a multicenter trial to investigate the efficacy of ivabradine to decrease perioperative myocardial injury. The intervention planned is complex and demands important resources. The investigators designed this pilot study to inform on the feasibility of the definitive large trial. This pilot study will also provide additional information that could help investigators improve the definitive large trial regarding recruitment, refinements to the study protocol and improving the participant's experience.

Start: October 2020
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease (SIHD). This is a multicenter randomized controlled trial with 5179 randomized participants with moderate or severe ischemia on stress testing. A blinded coronary computed tomography angiogram (CCTA) was performed in most participants with eGFR ?60 mL/min/1.73m2 to identify and exclude participants with either significant unprotected left main disease (?50% stenosis) or those without obstructive CAD (<50% stenosis in all major coronary arteries). Of 8518 participants enrolled, those that had insufficient ischemia, ineligible anatomy demonstrated on CCTA or another exclusion criterion, did not go on to randomization. Eligible participants were then assigned at random to a routine invasive strategy (INV) with cardiac catheterization followed by revascularization, if feasible, plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cardiac catheterization and revascularization reserved for those who fail OMT. SPECIFIC AIMS A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure in participants with SIHD and moderate or severe ischemia over an average follow-up of approximately 3.5 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT. B. Secondary Aims Secondary aims are to determine whether an initial invasive strategy compared to a conservative strategy will improve: 1) the composite of CV death or MI; 2) angina symptoms and quality of life, as assessed by the Seattle Angina Questionnaire; 3) all-cause mortality; 4) net clinical benefit assessed by including stroke in the primary and secondary composite endpoints; and 5) individual components of the composite endpoints. Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III per NIH Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III per NIH Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III per NIH

Start: July 2012
MRI of Myocardial Infarction

Heart failure (HF) is an enormous health burden affecting approximately 5.1 million people in the US and is the cause of 250,000 deaths each year. Approximately 50% of HF is caused by myocardial ischemia and requires immediate restoration of coronary blood flow to the affected myocardium. However, the success of reperfusion is partly limited by intramyocardial hemorrhage, which is the deposition of intravascular material into the myocardium. Hemorrhagic reperfusion injury has high prevalence and patients have a much greater risk of adverse left ventricular remodeling, risk of fatal arrhythmia, impaired systolic function and are hospitalized at a greater rate. Recent magnetic resonance imaging techniques have improved assessment of reperfusion injury, however, the association between MRI contrasts and reperfusion injury is highly unclear, and lacks specificity to IMH. Improved imaging of IMH and accurate knowledge about its spatial and temporal evolution may be essential for delivery of optimal medical therapy in patients and critical to identify patients most at risk for adverse ventricular remodeling. The overall goal is to investigate the magnetic properties of hemorrhage and develop MRI techniques with improved specificity to hemorrhage. New MRI techniques permit noninvasive assessment of the magnetic susceptibility of tissues and can target tissue iron. Therefore, the investigators hypothesize that MRI imaging of myocardial magnetic susceptibility can map hemorrhagic myocardium. The investigators will perform a longitudinal observational study in patients after reperfusion injury to validate these methods, compare the methods with conventional MR contrasts and develop MR methods for imaging humans.

Start: April 2018
Can Continuous Non-invasive Monitoring Improve Stability of Intraoperative Blood Pressure - A Feasibility Study.

Background During anaesthesia for repair of a broken hip, many patients experience low blood pressure. There have been many studies showing that patients who experience low blood pressure during anaesthesia are at increased risk of sustaining kidney or heart damage, strokes, having a post-operative infection, or dying. During anaesthesia, in most cases blood pressure is monitored using a cuff which inflates on the arm (the 'normal' way blood pressure is measured in a GP practice or hospital ward). This gives a reading each time the cuff goes up and down, every 3-5 minutes typically. There is a less well used way to measure blood pressure, using an additional cuff on the finger which gives a constant, continuous measure of blood pressure. We think that using this monitor, rather than the 'standard' monitor, will mean that low blood pressure is recognised more quickly, therefore treated more quickly, and will lead to patients having less exposure to dangerously low blood pressures. If this is the case, we hope that it will reduce how often patients experience kidney or heart damage, have an infection after surgery, suffer a stroke, and reduce the risk of death. Methodology To test this, we would need to run a large clinical trial comparing the continuous monitor to the standard monitor. This would be expensive and involve a great deal of work in a large number of hospitals, and so first we wish to determine whether the trial we would like to run is practical, and possible to deliver in the real world. To do this we plan to run the trial first on a small-scale feasibility (pilot) study, where we will recruit 30 patients, half of whom will have the standard monitor, and half of whom will have the continuous monitor. We will see what proportion of the patients who could enter the trial actually do so and complete it, and use it as an opportunity to iron out problems with the trial. If we find it is possible to run the trial on a small scale, we will apply for funding to run a full study. This will aim to answer the question of whether the continuous monitor improves the patient outcomes which were agreed during development with the patient public involvement group locally; rate of kidney damage, heart damage, stroke, post-operative infections, risk of death, and hospital length-of-stay. Expected outcomes and implications. We anticipate we will find the trial to be feasible with amendments to the way it is run, and if this is the case, we will apply to run the full scale trial. If this shows that using the continuous monitor improves the patient outcomes above, then it would represent new, significant evidence that may lead to the NHS adopting it's use as 'standard care' during anaesthesia for repair of a broken hip, and would like lead to similar trials in other operations where patients may benefit in a similar way.

Start: June 2019