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Myocardial Ischemia clinical trials

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NCT ID: NCT01504945 Terminated - Anemia Clinical Trials

Red Blood Cell Transfusion in Patients With Coronary Artery Disease (CAD)

Start date: February 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Patients with a low blood count (anemia) with stable or unstable coronary artery disease consistently show worse clinical outcomes. It is unclear whether this association is confounded since anemic patients tend to be also sicker i.e. have lower ejection fractions or more comorbidities and this would be the reason for the worse outcomes rather than anemia. The coronary arteries are a unique vascular bed insofar that across the cardiac circulation oxygen extraction is close to maximal at rest. Thus increases in demand can only be met by increases in blood flow and hemoglobin concentration since oxygen extraction is maximal at rest. It is natural to assume that maximization of oxygen delivery in the setting of active coronary syndrome (ACS) is beneficial to the patient since oxygen extraction and coronary blood flow is fixed. In fact, in most intensive care units patients with ACS are transfused to a HCT of 30%. However, retrospective analysis of trial data showed at best mixed results in clinical outcome when patients with ACS were transfused and in fact in some studies showed consistently worse outcomes than non-transfused patients. Similar disappointing results have recently published in patient who underwent coronary artery bypass grafting (CABG). This study is designed to determine the effect of red blood cell (RBC) transfusion on oxygen consumption, cardiac, microcirculatory and endothelial function in patients with active coronary artery disease. For this study active coronary artery disease will be defined as the patient having undergone within the past 4 days of recruitment either a myocardial infarction due to atherothrombosis (AHA type I myocardial infarction) or surgery for coronary artery bypass grafting. In specific this study will test the hypothesis whether RBC transfusions improves cardiac and vascular function in patients with a hematocrit of less than 30% with active coronary artery disease. Aims of this study are to determine whether RBC transfusion in patients with active coronary artery disease and anemia: - increases oxygen delivery to the peripheral tissues. - increases whole-body oxygen consumption. - decreases nitric oxide bioavailability, endothelial, microcirculatory, and myocardial function, and/or increases platelet aggregation

NCT ID: NCT01499654 Terminated - Clinical trials for Myocardial Infarction

Half-Dose Radiopharmaceutical in Wide Beam Reconstruction

REGA-1102
Start date: October 2011
Phase: N/A
Study type: Interventional

This study is recruiting patients already scheduled for a single photon emission computed tomography myocardial perfusion imaging (SPECT-MPI) test. SPECT-MPI is a nuclear imaging technique that uses a radioactive substance, or radiotracer, and special equipment to create three-dimensional (3D) images of the heart. Radiotracer is a radioactive dye that will make the structures of the heart visible and is routinely used to view blood flow in the heart, scan for damaged heart tissue, or assess heart function. For a routine SPECT-MPI test, the radiotracer is given in one dose at the beginning of the test, followed by taking resting images of the heart. For this study, researchers would like to administer half of the radiotracer, obtain resting images, administer the remainder of the radiotracer and obtain a second set of resting images. Participants will receive the same amount of radioactive material that would normally be given for this test; however, it will be administered in two half-doses. Participation in this study will add about 30 minutes to the time it takes to complete the routine test. The investigators expect to enroll about 160 subjects in this study at Northwestern.

NCT ID: NCT01489761 Terminated - Clinical trials for Coronary Artery Disease

LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)

Start date: January 2012
Phase: Phase 4
Study type: Interventional

This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.

NCT ID: NCT01474434 Terminated - Clinical trials for Coronary Artery Disease

Efficacy of LCQ908 on Cardiovascular Risk

im
Start date: March 2011
Phase: Phase 2
Study type: Interventional

This is a study designed to evaluate the potential for the LCQ908 to impact cardiovascular risk.

NCT ID: NCT01464671 Terminated - Clinical trials for Coronary Artery Disease

Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention

STATUS PCI
Start date: July 2009
Phase: Phase 4
Study type: Interventional

The objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin) versus unfractionated heparin (UFH) in patients presenting with stable angina or silent ischemia (positive stress test without chest pain) that undergo percutaneous coronary intervention (PCI). The primary endpoint of the study will be major and minor bleeding events, defined by the REPLACE-2 trial definition, during the index hospitalization and up to 30 days post discharge.

NCT ID: NCT01462721 Terminated - Clinical trials for Coronary Artery Disease

The eSVS® Mesh Randomized Post-Market Study

Start date: October 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.

NCT ID: NCT01454440 Terminated - Clinical trials for Coronary Artery Disease

The INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial (INSTANT)

INSTANT
Start date: October 2007
Phase: Phase 4
Study type: Interventional

Patients with stable coronary artery disease, undergoing PCI by means of implantation of >33 mm of DES, will be randomized single-blinded to eptifibatide plus unfractioned heparin according to the ESPRIT protocol vs placebo plus unfractioned heparin.

NCT ID: NCT01448005 Terminated - Myocardial Ischemia Clinical Trials

LifeVest Post-CABG Registry

Start date: February 2011
Phase: N/A
Study type: Observational

This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing arrhythmic death in this select population with high risk for sudden cardiac death (SCD). This is a pilot project to determine the feasibility of a larger-scale study.

NCT ID: NCT01443754 Terminated - Clinical trials for Coronary Artery Disease (CAD)

Hybrid Revascularisation by Combined Coronary Artery Bypass Graft (CABG) and PCI in Multivessel Coronary Disease

HYBRID
Start date: September 2011
Phase: N/A
Study type: Observational

The present study is designed as a prospective, single centre, open label, observational trial. The study will collect information about the medical care patients receive during their planned procedure(s). No new testing or procedures will be done. Patients elected for hybrid revascularization will be asked their written consent to the use of their personal data. Left internal mammary artery to the Left Anterior Descending Coronary Artery (LIMA-LAD)surgical revascularization will be performed first, followed by percutaneous revascularization of the other vessels in the frame of the same hospitalization. After discharge patients will attend clinic visits at 30 days and 12 months, as per usual clinical practice, and will be contacted by phone at 6 months after procedure. Angiographic follow-up will be performed in symptomatic patients, as clinically indicated.

NCT ID: NCT01436123 Terminated - Clinical trials for Coronary Artery Disease

Plasmonic Photothermal and Stem Cell Therapy of Atherosclerosis Versus Stenting

NANOM PCI
Start date: December 2010
Phase: Phase 1
Study type: Interventional

Intensive therapy with rosuvastatin 40 mg and ApoA-I Milano reduces the total atheroma volume (TAV) up to 6.38 or 14.1 mm3 respectively. Our previous bench studies PLASMONICS and NANOM First-in-Man trial documented TAV reduction up to unprecedented 79.4 and 60.3 mm3 respectively with high level of safety and feasibility. The completed randomized two arm (1:1) study (NANOM-PCI) with parallel assignment (n=62) assessed (NCT01436123) the safety and feasibility of the delivery technique for nanoparticles (NP) using micro-injection catheter (with intravascular intramural injection of allogeneous stem cells carrying NP after MSCT-, IVUS- and OCT-guided mapping of the vessel), and plasmonic photothermal therapy of atherosclerosis combined with stenting (Nano group, n=32) versus stenting with Xience V cage (Stenting group, n=30). The primary outcome was TAV at 12 months. The mean reduction of TAV at 12 months in Nano group was -84.1 mm3 (95% CI: SD 28.3; min -52.4 mm3, max -99.1 mm3; p<0.05) versus +12.4 mm3 in case of stenting (p<0.05 between groups). 42/62 patients (68%) in Nano group passed the Glagov threshold of a 40% plaque burden with mean plaque burden (PB) 36.2% (95% CI: SD 9.3%, min 30.9%, max 44.5%). The increase of the minimal lumen diameter was 61.2 and 63.3% at 12 month follow up in groups respectively. The serial assessment of VH-IVUS showed a significant decrease at 12 months in the dense calcium area, fibrous and fibro-fatty tissue with fulminant necrosis due to thermolysis in Nano-group, whereas an increase of fibrous and fibro-fatty components in stenting arm. We have documented 2 vs 3 cases of the definite thrombosis and 3 vs 5 cases of target lesion revascularization in groups respectively. The analysis of the event-free survival of the ongoing clinical follow-up shows the significantly lower risk of cardiovascular death in Nano group if compare with conventional stenting (93.4% vs 86.7%; p<0.05). Plasmonic resonance-mediated therapy using noble-metal NP associated with significant regression of coronary atherosclerosis. Tested delivery approach has acceptable safety and efficacy for atheroregression below a 40% PB. The investigators hypothesize that multistep approach with the use of stent in acute care unit, and then subsequent transcatheter micro-injection with nanoparticles can resolve atherosclerosis, stop and regress atherogenesis, remodulate or even rejuvenate arteries. Stem cells in patch can be good carriers for nanoparticles as well as high-effective metabolic vectors (paracrine-like regulation of alive cells and via bioactive products of cell lysis after detonation of nanoparticles) for the treatment of plaque on site. Gold nanoparticles with silica-iron oxide shells promise high-energy plasmonic photothermic burning or melting effect under the near-infrared laser irradiation onto the lesion. Thus the investigators expect complex two-side effect on the plaque with protected lumen and adventitia. Novel discoveries in atherogenesis, and development of nanobiotechnologies with potentials for the management of atherosclerosis leads us to the quest of new approaches. The investigators still cannot really effectively treat atherosclerosis. The investigators management is more symptomatic, and lipid-pool or inflammation-oriented! The investigators cannot manage non-organic part (mineral deposits, calcified necrotic core, partially collagen and fibrotic tissue) and total plaque volume Surgery and invasive procedures is just focused on blood flow restoration (just manipulate the form of plaque) + concerns of clinical and technical restrictions (incl. alien body - stent) + risk of restenosis or subacute 'fatal' in-stent atherothrombosis + graft survival/ occlusion + surgery-related complications High rate of short- and long-term complications and readmissions. Regression of atherosclerosis in fact is still a dream. The investigators offer an alternative to stenting and may be cardiac artery bypass surgery (CABG). Our approach can really allow to rejuvenate arteries, Plasmonic photothermal therapy (PPTT) can burn plaque, but stem cells and bioengineered structures promise restoration of the vessel wall. Our personal previous data showed that PPTT can 1.6-fold reduce a volume of plaque with most optimal long-term result in subsets with the use of SPCs as a delivery approach. The most optimal delivery systems of NPs into the plaque are the on-artery bioengineered patch and ferro-magnetic approach.