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Coronary Disease clinical trials

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NCT ID: NCT02716363 Recruiting - Clinical trials for Coronary Artery Disease

Rotational Atherectomy for Calcified lEsion By Smart Angioplasty Research Team (SMART-RACE)

Start date: November 1, 2015
Phase: N/A
Study type: Interventional

Current guidelines recommend the use of rotational atherectomy (RA) for preparation of heavily calcified or severely fibrotic lesions that cannot be crossed by a balloon or adequately dilated before planned stenting (bailout situations). RA emerged in the 1990s as one of several tools to treat luminal obstruction via physical removal of plaque. Although initially explored as an alternative to balloon angioplasty, RA has shown favorable acute results in facilitating stent delivery and adequate expansion, particularly those affected by heavy calcification.Drug-eluting stents (DES) have substantially reduced re-stenosis rates in randomized clinical trials evaluating simple de novo coronary artery lesions and have also shown favorable results when implanted in complex lesions and patients, but higher event rates are observed when treating such subsets compared with simple lesions even with newer generation DES. However, there are limited data on evaluating the safety and effectiveness of RA followed by DES implantation for heavily calcified lesions in contemporary practice. Recent randomized controlled trial shows that RA before paclitaxel eluting stent implantation as first generation DES was not superior to paclitaxel eluting stent implantation without prior RA in reducing the primary endpoint of in-stent late luminal loss at 9 months, indicating that RA does not increase the efficacy of DES in patients with moderate to severe calcified lesions. However, there were only 15 (12.5%) crossovers from standard therapy to rotablation because of failure of balloon or stent delivery or suboptimal balloon expansion despite the use of a noncompliant balloon. Accordingly, procedural and fluoroscopy times were longer in the elective RA and procedural complications occurred equally in both elective RA and bailout RA. These findings might cause by a substantial portion of enrolled population have moderate calcified lesions, but not severe calcified lesions. In particular, everolimus-eluting stent (EES) as newer generation DES could act synergistically in heavily calcified lesions as RA could avert stent coating damage and EES could effectively suppress neointimal proliferation. Therefore, we compare in-hospital and long-term efficacy or safety of elective RA versus bailout RA and low-volume operator versus high-volume operator in patients with severe calcified lesions treated with EES.

NCT ID: NCT02702063 Recruiting - Clinical trials for Coronary Artery Disease

Calibrating Cardiac Output Measurement of Electrical Cardiometry With Transthoracic Echocardiography

EC vs TTE
Start date: October 2015
Phase: N/A
Study type: Interventional

Cardiac output (CO) is a key variable when describing the cardiovascular system. Electrical cardiometry (EC) is a non-invasive method in measuring stroke volume and cardiac output. However, its accuracy has been inconsistent. Therefore Martin et al. have compared measurements with echocardiographic measurements and propose calibration with left ventricle outflow tract (LVOT)-measurements obtained from transthoracic echocardiography (TTE). This study was performed in pregnant women at term. Goal of this study is to validate their formula in non-pregnant outpatients undergoing echocardiography for cardiology work-up. Secondary aim is to perform a leg raising test and to compare changes in stroke volume observed with either EC or TTE.

NCT ID: NCT02671123 Recruiting - Clinical trials for Coronary Artery Disease

Does Co-registration of OCT and Angiography Reduce Geographic Miss of Stent Implantation?

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

The purpose of this study is to determine whether co-registration of OCT and angiography reduce geographic miss defined as stent edge dissection or significant residual stenosis at stent edge after stent implantation during percutaneous coronary intervention.

NCT ID: NCT02667028 Recruiting - Clinical trials for Coronary Heart Disease

Retrospective Evaluation of Prognosis of Pci Patients Using Network Data in SHengjing Hospital

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

Coronary heart disease (CHD) has a serious health threaten to population. PCI is a well-proved measure in CHD management. However, the knowledge about the real-life PCI use and how evidence-based therapies in routine clinical practice is limited. In a large-scale hospital in Northeast China, the investigators will examine various factors of 3007 consecutive PCI inpatient cases from January 1, 2010 to October 31, 2014. The medical records will be reviewed and abstracted to evaluate the clinical treatment pattern and outcomes. Basic data and innovative evidence will accelerate evidence-based clinical practice, and improve patients' outcomes in future finally.

NCT ID: NCT02644434 Recruiting - Clinical trials for Coronary Artery Disease

Conventional Versus Intentional StraTegy in Lesions With High Risk PrEdiction of Side Branch OccLusion in InterVEntion

CIT-RESOLVE
Start date: December 1, 2016
Phase: N/A
Study type: Interventional

The purpose of the present study is to investigate if intentional strategy (a more aggressive side branch protection strategy: elective two-stent or jailed balloon technique) is associated with significant reduction of side branch occlusion rate compared to conventional strategy (provisional two-stent strategy or jailed wire technique) in patients at high risk of side branch occlusion (V-RESOLVE score≥12).

NCT ID: NCT02642419 Recruiting - Atrial Fibrillation Clinical Trials

Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study

AFIRE
Start date: January 2015
Phase: Phase 4
Study type: Interventional

In patients with atrial fibrillation (AF) complicated with coronary artery disease (CAD), antiplatelet drugs are commonly used for the prevention of recurrence of stent thrombosis and cardiovascular events in combination with anticoagulant drugs. Based on the observations that the incidence of hemorrhagic complications increased when an antiplatelet drug was administered in combination with vitamin K antagonist (VKA), the guidelines for antithrombotic therapy after PCI in the US and EU recommend that DAPT (dual anti-platelets therapy) should be used in AF-complicated CAD patients for as short a time as possible following single anti-platelet and VKA, and that monotherapy with VKA should be started from one year after PCI. In 2013 the European Heart Rhythm Association (EHRA) published the guidelines for the use of NOACs in NVAF patients, which state that NOACs may have advantage to VKAs in terms of anti-thrombotic effects in NVAF patients undergoing PCI. However, no clinical evidence has ever been generated to reveal the efficacy and safety of mono-drug therapy with a NOACs in stable CAD patients one year or more after PCI. AFIRE study is planned to evaluate the efficacy and safety of mono-drug therapy with a rivaroxaban in stable CAD patients. Among NOACs, rivaroxaban was chosen because of the evidence in Japanese patients and the results of a sub-analysis of ROCKET AF suggesting that rivaroxaban is more effective than VKA in reducing the incidence of myocardial infarction (MI).

NCT ID: NCT02635477 Recruiting - Clinical trials for Coronary Artery Disease

Get Going: Accelerometer-Based Intervention to Promote Physical Activity in Frail Older Adults

AAIMASP
Start date: January 2016
Phase: N/A
Study type: Interventional

A multicenter prospective randomized clinical trial testing the hypothesis that a patient-centered actigraphy intervention will result in increased physical activity for frail older adults increase during the critical first 30 days after a cardiovascular hospitalization.

NCT ID: NCT02635230 Recruiting - Stroke Clinical Trials

What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 2.

WOEST 2
Start date: June 2014
Phase:
Study type: Observational [Patient Registry]

The optimal antithrombotic therapy for patients with atrial fibrillation (AF) with a CHA2DS2-VASc score ≥1 with concomitant acute coronary syndrome (ACS) or revascularisation by percutaneous coronary intervention (PCI) with stenting, is still unknown. For these patients current North American and European guidelines recommend a triple therapy strategy, including vitamin K antagonists (VKA), aspirin and clopidogrel. A major drawback of this triple therapy strategy is a significant increase in the risk of major bleeding. Furthermore, the ommitance of aspirin and the introduction of more potent P2Y12 inhibitors as well as the non-vitamin K oral anticoagulants (NOAC), created numerous new antithrombotic treatment strategies for these patients with overlapping conditions. To date, evidence on the risks and benefits of these new antithrombotic treatment strategies is lacking. The WOEST 2 Registry aims to improve medical care for patients with AF and/or a heart valve prosthesis ánd undergoing coronary revascularisation through a better understanding of their demographics, antithrombotic management and related in-hospital and long-term outcomes. The WOEST 2 Registry will provide data to support benchmarking of antithrombotic treatment patterns and patient outcomes. Objective: To assess the different management patterns and related in-hospital and long-term safety and efficacy outcomes of combined use of chronic oral anticoagulation and a P2Y12 inhibitor in patients with atrial fibrillation and/or a heart valve prosthesis undergoing coronary revascularisation.

NCT ID: NCT02634086 Recruiting - Clinical trials for Coronary Artery Disease

Long-term Outcome of Triple-vessel Coronary Artery Disease Underwent Three Different Strategies (LOTUS)

LOTUS
Start date: April 2004
Phase: N/A
Study type: Observational

The study is to determine the long-term outcome of patients with coronary triple vessels disease (TVD) in the real world of China, by three different treatment strategies: percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG) or optimal medication therapy (OMT).

NCT ID: NCT02632617 Recruiting - Clinical trials for Coronary Artery Disease

coRonary assEssment of Preoperative vaLvulopathy pAtients Using ComputEd Tomographic Angiography (REPLACE)

REPLACE
Start date: December 2015
Phase: N/A
Study type: Observational [Patient Registry]

Preoperative detection of combined coronary artery disease by invasive coronary angiography (ICA) is recommended in American Heart Association (AHA)/American College of Cardiology (ACC) guidelines for most patients (>40 yrs male or postmenopausal female) scheduled for heart valve surgery, but the low incident rate of coronary artery disease implied guidelines for the vast majority who ultimately will not undergo revascularization. Computed tomography angiography (CTA) has emerged as an alternative diagnosis procedure, which has the following advantages: non-invasive, low cost, provide information of lung and mediastinum. Our study is to evaluate the feasibility of computed tomography, instead of conventional invasive coronary angiography in evaluating coronary artery lesion prior to the heart valvular operation.