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Myocardial Ischemia clinical trials

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NCT ID: NCT01848106 Terminated - Clinical trials for Coronary Artery Disease

A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI

Regulate
Start date: September 2013
Phase: Phase 3
Study type: Interventional

This study is designed to determine the efficacy of REG1 compared to bivalirudin in preventing periprocedural ischemic complications and major bleeding in patients undergoing PCI as a treatment for CAD. Bivalirudin has been studied in patients undergoing PCI in both ACS (NSTEMI and unstable angina [UA]) and elective PCI. In comparison to UFH, bivalirudin has shown similar rates of ischemic events while demonstrating a significant reduction in bleeding and an improved net clinical benefit. Evidence from previous studies indicates that pegnivacogin represents an extremely potent, chemically unique anticoagulant that can be reversed by anivamersen across multiple populations (refer to Section 1.2.2). The question that still remains is whether Factor IX (FIX) inhibition by pegnivacogin can result in fewer ischemic events than a previously studied agent while active control with anivamersen can preserve the benefit of reduced bleeding. The purpose of this study is to evaluate REG1 in an adequately powered definitive study with an open-label, multi-center, active-controlled, randomized design to answer that question.

NCT ID: NCT01847391 Completed - Clinical trials for Ischemic Heart Disease

A Phase 1 Study to Assess the Safety,Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects

Start date: May 2013
Phase: Phase 1
Study type: Interventional

This is a phase 1, single-blind, randomized, placebo-controlled, multiple ascending dose study aimed to assess the safety, tolerability, and pharmacokinetics of GS-6615 in healthy subjects.

NCT ID: NCT01844843 Completed - Clinical trials for Coronary Artery Disease

Optical Frequency Domain Imaging (OFDI) Assessed Strut Coverage of New Terumo DES

DISCOVERY123
Start date: January 2014
Phase: N/A
Study type: Interventional

Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES), coverage of the stent struts by new tissue. The evaluation will be performed by means of intravascular imaging technology (optical frequency domain imaging, OFDI). Renewed tissue coverage over the implanted stent struts prevents direct contact between blood and metal/polymer, which could lead to adverse events: patients need to take blood-thinning drugs to prevent these events. Ous new stent has drug and polymer only on the outside of the stent, and the polymer is degraded by the body leaving a bare metal stent after 3-4 months. This should allow fast coverage of the struts, and might allow to reduce duration of the supportive medical treatment. Our hypothesis is that <20% of the struts remain uncovered at 3 months after implantation, as assessed by OFDI.

NCT ID: NCT01844284 Completed - Clinical trials for Coronary Artery Disease

AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorbâ„¢ BVS) in Japanese Population

ABSORB JAPAN
Start date: April 2013
Phase: N/A
Study type: Interventional

Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorbâ„¢ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent.

NCT ID: NCT01840969 Completed - Clinical trials for Three Vessel Coronary Artery Disease

Association of Carotid Arterial Circumferential Strain With Left Ventricular Function and Hemodynamic Compromise During Off-pump Coronary Artery Bypass Surgery

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

This study is aimed to evaluate the association of common carotid artery circumferential strain with the echocardiographic parameters of left ventricular function and the degree of actual hemodynamic deterioration in patients undergoing multi-vessel off-pump coronary artery bypass with preserved left ventricular ejection fraction.

NCT ID: NCT01840696 Withdrawn - Clinical trials for Coronary Artery Disease

Phase Analysis and Obstructive CAD on Rubidium PET

Start date: October 2013
Phase: Phase 2
Study type: Interventional

Rubidium myocardial perfusion PET is an imaging test used to diagnose patients with abnormal blood flow to the heart secondary to narrowing of the heart vessels. Phase analysis is a computer method that is applied after the PET test is done. It is used to determine when a region of the heart contracts relative to other heart regions in the heart beating cycle. Initial data suggest that regions of the heart with abnormal blood flow change the pattern of contraction from rest to stress conditions. That is, regions of the heart with abnormal blood supply become dyssynchronous when compared to the normal regions of the heart. This study will investigate whether phase analysis may aid the visual interpretation of rubidium myocardial perfusion PET studies by determining the areas of the heart that are not beating in synchrony with the normal heart regions. This information will be used as a proxy for poor blood supply. The gold standard will be coronary angiography by which the percent narrowing of the heart vessels is assessed.

NCT ID: NCT01839162 Completed - Myocardial Ischemia Clinical Trials

RAdiation Dose In percutAneuos Coronary Procedures Through TransradIal apprOach Using Dedicated radiatioN Shields

RADIATION
Start date: April 2013
Phase: N/A
Study type: Interventional

During percutaneous coronary interventions standard operator radio-protection is generally ensured using a lead apron, a thyroid lead collar, low leaded flaps, an upper mobile leaded glass suspended from the ceiling and leaded glasses. Previous studies showed that adding a bismuth-barium radiation shield drape on the patient right arm or using a pelvic lead shield on the patient, the radiation dose adsorbed by operators was significantly reduced even if was higher compared to transfemoral approach. No studies evaluated the effect of both adjunctive shields placed in the same patient. Aim of our randomized study is to evaluate if the combination of a shield drape on the patient right arm and a pelvic lead shield during transradial percutaneous coronary procedures may reduce the radiation dose adsorbed by operators compared to the use of only one shield or none. All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study. Eligible patients will be randomized (using a computer generated randomization sequence) in 4 groups: 1. use of a pelvic shield drape 2. use of a shield drape on the patient right arm 3. use of a pelvic shield drape and a shield drape on the patient right arm 4. Any adjunctive shield drape (only standard radio-protection) For each group a further internal randomization will be performed in order to compare the right or left radial transradial approach. Each operator will be equipped with dedicated dosimeters placed at left wrist and at thorax level outside the lead apron. Since December 2013 the operators are equipped with a further dosimeter at head level. Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by operators and detected by the electronic dosimeters. Secondary end-point are: 1. Radiation dose adsorbed by operators according to the radial access (right versus left) 2. Radiation dose adsorbed by the patients 3. Radiation dose adsorbed at head level.

NCT ID: NCT01839071 Completed - Clinical trials for Coronary Artery Disease(CAD)

Influence of Vasculary Inflammation on Development of Diabetes

Start date: June 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate if patients with coronary heart disease have higher risk to develop diabetes mellitus among the following two years. The examination of biomarkers taken from blood and fat issue shall provide which factors could be responsible for development of diabetes mellitus.

NCT ID: NCT01838746 Active, not recruiting - Clinical trials for Coronary Artery Disease

CRAGS (Coronary aRtery diseAse in younG adultS)

CRAGS
Start date: April 2013
Phase: N/A
Study type: Observational

Young patients requiring myocardial revascularization are generally considered at low operative risk, but data on their immediate and late outcome are scarce. The decision-making process in these young patients is complicated by the potentially aggressive nature of premature coronary artery disease and their likely long expectancy of life, which expose them to a significantly higher risk of recurrent coronary events as well as the need of repeat revascularization. The lack of data on long-term outcome as well as on operative details (in particular, on the use of arterial grafts) and peri- and postoperative medication prevent any conclusive results on the durability either of coronary artery bypass grafting (CABG) or of percutaneous coronary intervention (PCI) in these young patients. Furthermore, recent advances in stents technology as well in peri- and postoperative medical treatment indicate the need a comparative study to define the baseline characteristics of patients aged < 50 years undergoing either PCI or CABG and to evaluate their current immediate and late outcome.

NCT ID: NCT01838356 Completed - Depression Clinical Trials

Intracranial Atherosclerosis and Depression After Coronary Artery Bypass Graft

NOAHS
Start date: September 2012
Phase: N/A
Study type: Observational

The purpose of the study is to examine if blood flow in the brain before coronary artery bypass graft surgery has an effect on depression after surgery. The main hypothesis of the study states that pre-surgical blood flow in the brain will be an independent risk factor for depression after surgery after adjusting for other risk factors such as gender, pre-CABG depression, social support, medical comorbidity burden, socioeconomic status, and neuroticism.