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Heart Diseases clinical trials

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NCT ID: NCT02786134 Completed - Diabetes Mellitus Clinical Trials

Coronary Flow Reserve to Assess Cardiovascular Inflammation (CIRT-CFR)

CIRT-CFR
Start date: April 2016
Phase: N/A
Study type: Interventional

Coronary flow reserve (CFR, calculated as the ratio of hyperemic over rest myocardial blood flow) is emerging as a powerful quantitative prognostic imaging marker of clinical cardiovascular risk. CFR provides a robust and reproducible clinical measure of the integrated hemodynamic effects of epicardial coronary artery disease (CAD), diffuse atherosclerosis, and microvascular dysfunction on myocardial tissue perfusion. Inflammation is a key mediator of this constellation of abnormalities, affecting the entire coronary vasculature, but no clinical trial to date has shown that directly reducing inflammation lowers cardiovascular event rates. As such, the recently launched Cardiovascular Inflammation Reduction Trial (CIRT) provides a unique opportunity for mechanistic investigation of the impact of anti-inflammatory therapy on changes in CFR as a reflection of coronary vascular dysfunction, which may precede clinical outcomes, particularly in patients at high-risk of events. The investigators are ideally positioned to examine the impact of inflammation on CFR, having extensive experience in both the quantitation of CFR using clinically-integrated dynamic positron emission tomography (PET) and the ability to assess its association with cardiovascular outcomes. The central hypothesis of this ancillary proposal, CIRT-CFR, is that reducing systemic inflammation using low-dose methotrexate (LDM) will, compared to placebo, quantitatively improve myocardial blood flow and coronary flow reserve as measured by PET over one year, in stable CAD patients with type 2 diabetes or metabolic syndrome enrolled in CIRT. In so doing, improvement in coronary vasoreactivity, endothelial function, and tissue perfusion may have beneficial effects on myocardial mechanics, left ventricular deformation and function and, ultimately, symptoms and prognosis.

NCT ID: NCT02781545 Completed - Clinical trials for Heart Defects, Congenital

Motor Development of Children That Have Surgery as Newborns for Complex Congenital Heart Disease

Start date: May 2015
Phase:
Study type: Observational

Infants requiring surgery in the neonatal period for complex congenital heart diseases are at risk for developmental problems. For infants with congenital heart diseases with admixture physiology and single ventricles, optimal circulation is associated with signs of adequate systemic perfusion and a systemic arterial oxygen saturation typically between 75% to 90%. Infants are often unable to withstand standardized developmental testing during early infancy due to medical fragility and sternal precautions after surgery. Evaluation of the quality of spontaneous movements and movement variability is a good alternative. The quality of general movements in early infancy is a valid predictor of neurological disorders in high risk infant groups and is assessed with short periods of video-recorded observations. This methodology has yet to be studied in infants with complex congenital heart disease that require surgery as neonates. For older infants, the Infant Motor Profile (IMP) is a promising tool to document developmental outcome.

NCT ID: NCT02779946 Completed - Coronary Disease Clinical Trials

Non-invasive Liver Screening for Risk Assessment for Coronary Heart Disease

NILS-R-CHD
Start date: October 2015
Phase: N/A
Study type: Observational

Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the metabolic syndrome, which is one of the major risk factors of coronary heart disease (CHD). CHD is the most important manifestation of atherosclerosis, because of its immense morbidity and mortality. Transient elastography (TE, Fibroscan®) including the currently developed controlled attenuation parameter (CAP) is a non-invasive method for evaluation of liver fibrosis and steatosis, which is already implemented in routine care of patients with NAFLD. Hypothesis: The use of TE with CAP as screening for NAFLD might be an easy tool for risk assessment for CHD. Methods: Patients scheduled for routine coronary angiography will be screened for manifestation of NAFLD by TE including CAP, conventional ultrasound, clinical and laboratory parameters. Patients will be stratified for the presence of CHD based on the angiography results and correlation analysis with liver fat content will be performed. NFALD screening will be validated in a subgroup by MR-based measurements.

NCT ID: NCT02776267 Completed - Clinical trials for Coronary Heart Disease

Percutaneous Coronary Intervention With the Angiolite Drug-eluting Stent: an Optical Cohenrece Tomography Study

Start date: May 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to perform a first-in-man assessment of feasibility, exploratory efficacy and clinical performance of the novel Angiolite drug-eluting stent (iVascular, Barcelona, Spain) utilizing intracoronary optical coherence tomography (OCT).

NCT ID: NCT02775565 Completed - Heart Disease Clinical Trials

Initial Experience With the AngioVac Venous Drainage Cannula

Start date: February 2016
Phase: N/A
Study type: Observational

This is a retrospective, record-based study of approximately 100 patients across up to 12 centers within the United States. All patients who have been treated with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit will be considered for study participation. Eligible subject must meet all of the inclusion criteria and none of the exclusion criteria to be considered enrolled in the study. The purpose of the study is to describe initial experience with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit.

NCT ID: NCT02771873 Completed - Clinical trials for Coronary Heart Disease

Programme of Lifestyle Intervention in Families for Cardiovascular Risk Reduction

PROLIFIC
Start date: July 2015
Phase: N/A
Study type: Interventional

The overall goal of the study is to test the effectiveness and sustainability of an integrated care model for managing cardiovascular risk in individuals with family history of premature coronary heart disease (CHD). This care model involves: 1. screening for cardiovascular risk factors, 2. providing lifestyle interventions for prevention and management of cardiovascular risk factors, 3. providing a framework for linkage to appropriate primary health care facility and 4. active follow-up of intervention adherence. Initially, a formative qualitative research component will gather information on understanding of diseases, barriers to care, specific components of the intervention package (for example, context specific ways to enhance physical activity and to reduce prolonged sitting time, ways to improve diet etc.) and feedback on the intervention strategies (lifestyle education, care and linkage coordination). Then a randomized controlled trial involving ~700 families and 1400 participants will be used to determine whether an integrated care model is effective in reducing or halting the progression of CHD risk factors and risk factor clustering in families. The sustainability and scalability of this intervention will be assessed through economic and qualitative lenses to estimate value and acceptability. Scalability will be informed by cost-effectiveness and acceptability of the integrated cardiovascular risk reduction approach.

NCT ID: NCT02770651 Enrolling by invitation - Clinical trials for Coronary Artery Disease

Late Stent Strut Apposition and Coverage After Drug-Eluting Stent Implantation by OCT in Patients With AMI

Start date: May 2016
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa Rosa, CA, USA) implantation in patients with AMI at 12 months.

NCT ID: NCT02769624 Terminated - Clinical trials for Congenital Heart Disease

Acute Effects of Inhaled Treprostinil in Fontan Patients

Start date: February 21, 2017
Phase: Phase 2
Study type: Interventional

In this pilot study investigators propose to explore the effects of a locally delivered inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood flow, venous pressure response and vascular function in stable Fontan patients. Investigators will also assess the effects of resting and acute rises in exercise induced systemic venous pressure on liver stiffness and will also assess whether treprostinil will attenuate the acute stiffness increase that investigators expect to see. This will be a prospective, randomized, double-blinded placebo controlled, crossover trial. Following recruitment and informed consent, each participant will undergo three study visits, including baseline testing (visit 1), followed by two sets of exercise and vascular function tests (visit 2 and visit 3) at CCHMC. Twenty-six patients will be enrolled in this study.

NCT ID: NCT02768116 Active, not recruiting - Clinical trials for Coronary Heart Disease

The Study of Active Transfer of Plaque Technique for Non-Left Main Coronary Bifurcation Lesions

Start date: June 2016
Phase: N/A
Study type: Interventional

A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Non-Left-Main Coronary Bifurcation Lesions.

NCT ID: NCT02767154 Completed - Heart Disease Clinical Trials

Dextran-based Priming vs. Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery

Start date: May 2016
Phase: Phase 2
Study type: Interventional

This study will compare two priming solutions for extracorporeal circulation, one based on Dextran 40, one based on crystalloid and mannitol. Primary endpoint is oncotic pressure during cardiopulmonary bypass. Secondary endpoints included fluid balance and organ functions.