View clinical trials related to Ischemic Cardiomyopathy.
Filter by:This is a prospective open label single blinded multi-centre observational study involving a study group of patients already undergoing implantable cardioverter-defibrillator (ICD)(including Cardiac resynchronisation therapy device (CRT-D)) implant. A standard 30-minute electrophysiological (EP) cardiac stimulation protocol will be performed at the end of the ICD implant at baseline. This EP test will be performed whilst measuring a 12-lead ECG and will be correlated with event rates to establish their effectiveness in predicting arrhythmia risk. The minimum follow up period should be 18 months and maximum of 3 years, which is how long the study is funded for. This study is not randomised as all study patients will be receiving the EP study performed at baseline. A minimum of 440 patients will be recruited to document event data at standard clinical ICD follow up intervals - equating to a maximum of 6 visits. Blinding will be maintained at the core lab were the ECG analysis will be performed by a nominated researcher who will not have details of patient health status.
The purpose of this study is to evaluate the safety and tolerance of a new intravenous diagnostic agent, SeeMore or EVP 1001-1, in patients with Cardiovascular Disease (MEMRI scan). The initial phase of this study, NCT01989195 enrolling a total of 6 patients, has been closed. This second phase adds 10 patients in a safety cohort and 60 additional patients for a total of 70 patients.
This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cells both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by transendocardial injection in subjects with ischemic cardiomyopathy.
We hope to introduce a novel MRI contrast agent with SeeM ore ™ that directly defines viable myocardium. Identifying viable myocardium non-invasively using cardiac MRI is still a moving target and a question we plan to answer more definitively with the SeeMore ™ contrast. Though well tested. in small and large animals and Phase I & II clinical trials, we would like to determine the efficacy of the SeeM ore TM contrast further in a clinical setting. SeeM ore ™ is a new manganese (Mn)-based intravenous imaging agent being developed to enhance magnetic resonance imaging (MRI). While Mn has long been known to have desirable magnetic and kinetic properties for MRI, use in humans was not initially possible due to cardiovascular depression and electrocardiogram (ECG)changes, including prolongation of PR and QTc intervals, associated with intravenous administration [1-5]. Chelation of Mn, as had been done with gadolinium for use with MRI, provided relevant safety, but sacrificed desirable magnetic and kinetic properties [6]. SeeM ore rM provides Mn in a form that maintains the desired magnetic and kinetic properties while overcoming the cardiovascular toxicity of Mn. SeeM ore rM is taken up into heart cells .(primarily via addition of calcium to avoid cardiotoxic effects; please refer to US patent #5,980,863). The potential to distinguish healthy heart tissue from unhealthy heart tissue based on a specific sustained pattern of enhancement provides a basis for evaluating the performance of SeeM ore rM in heart patients. MRI offers benefits over other imaging technologies. Relative to radioactive nuclear imaging procedures, MRI is 3-dimensional, provides good soft tissue discrimination, and is of high spatial and temporal resolution. These features have been reported to identify smaller defects (e.g., subendocardial infarcts) and match angiographic results more closely than other modalities such as SPECT [7,8]. It may be possible to enhance the utility of MRI for heart disease further through the use of an imaging agent that is specifically taken up into heart cells. SeeM ore rM is the only cardiac-specific agent being developed for this purpose. Unlike nuclear perfusion agents, SeeM ore rM is not radioactive and does not require special handling, shielding, transport or storage. In addition, the specific pattern of enhancement achieved in the heart muscle persists over time, offering potential .benefits over the nonspecific extracellular agents currently available for MRI or X-ray/CT procedures. This feature allows full use of the high resolution of MRI, since there is not a trade-off of high spatial resolution for temporal (first-pass) resolution. It is anticipated the features offered by SeeMore™ along with the high resolution, three dimensional attributes of MRI will result in higher accuracy than is available with other current modalities in practice, including stress echocardiograms, cardiac MRI using gadolinium contrast and nuclear studies such as SPECT and PET. This will be evaluated in this study and serve as the basis for pivotal registration studies. All components of SeeMore™ are USP and are approved for use as drugs in man, orally and/or intravenously. A summary of the Phase I safety and PK (pharmacokinetics)study are provided below. The Phase I study evaluated the safety and tolerance of SeeM ore ™ in humans, with special emphasis on cardiovascular safety, and assessed its PK profile.
This study will assess whether percutaneous coronary intervention (angioplasty of the heart arteries) can improve survival and reduce hospitalization in patients with heart failure due to coronary disease, who have been treated with the best contemporary medical therapy.
Despite pharmacologic advances for the treatment of congestive heart failure (HF), sudden cardiac death (SCD) and pump failure remain the leading causes of mortality in patients with HF. Although, SCD is poorly understood, implantable cardiac defibrillators (ICD) have been shown to be an effective, but costly therapy in preventing SCD. At present, left ventricular systolic dysfunction is our best independent predictor of SCD, but only moderately predicts those patients who will eventually benefit from the placement of an ICD and, in most cases, left ventricular (LV) systolic dysfunction is a non-modifiable risk factor once acquired. As a result, there exists an intensive search for biomarkers that could improve the prediction of SCD and have the potential for risk factor modification. Experimental and clinical evidence has established that inflammation plays a critical role in stable coronary disease, plaque rupture, acute myocardial infarction, heart failure, and SCD. Studies at our institution have demonstrated that elevated levels of hsCRP and Interleukin-6 are predictive of arrhythmic SCD; however, the mechanism of causing this increased risk is unclear. Another well-known risk factor for SCD is abnormal sympathetic innervation. The most robust clinical test of sympathetic innervation to date is Iodine-123 Metaiodobenzylguanidine (MIBG) imaging with gamma scintigraphy. MIBG imaging has emerged as one of our strongest predictors of SCD by detecting sympathetic nervous system abnormalities in patients with HF. Preclinical and clinical evidence suggests that myocardial inflammation adversely affects myocardial innervation. Based on these findings, the investigators hypothesize that elevated levels of inflammatory biomarkers are associated with abnormal sympathetic innervation as measured by MIBG imaging. The investigators aim to establish the strength of this association. This proposal will leverage unique access to the largest, most extensively phenotyped cohort of patients who have undergone ICD implantation for primary prevention of SCD, the PRospective Observational Study of the ICD in SCD, (PROSE-ICD).
This study will evaluate the safety and efficacy of intracoronary injection of mesenchymal stem cells (MSCs) to repair heart function in patients with myocardial ischemia.
The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of a novel mesenchymal precursor cell type (iMP) in patients with ischemic cardiomyopathy at the time of coronary artery bypass grafting.
The purpose of this study is to evaluate the use of radial strain imaging using speckle tracking analysis to predict the response to CRT in patients with ischemic cardiomyopathy (ICMP) with NYHA functional class 2-4 heart failure and a standard guideline-based CRT indication. Thus assessing the value of lead localization determined by radial strain imaging in a prospective, randomized manner.
The purpose of this study is to determine whether mechanical alternans (alternating strong and weak heart beats with a constant beat-to-beat interval), can be used to predict malignant ventricular arrhythmias, requiring defibrillation or appropriate ICD therapies, and to predict progression of heart failure and death.