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Myocardial Ischemia clinical trials

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NCT ID: NCT03570762 Completed - Clinical trials for Coronary Artery Disease

Long Term Outcomes Of Hybrid Percutaneous Approach

Start date: February 1, 2015
Phase:
Study type: Observational

Bioresorbable vascular scaffolds (BVS) are considered as a new revolution in coronary intervention due to their potential advantages for long term follow up. However, current generation BVS have also some drawbacks that restrict the use for complex lesions. Using BVS and drug eluting stents (DES) together -implanting DES for BVS inappropriate segments -may be a feasible option to avoid the disadvantages of permanent foreign body and to reduce very late adverse events. In this context, we investigated the clinical outcomes following treatment with hybrid strategy with concomitant use of BVS and DES for complex lesions. A single center retrospective cohort was performed enrolling 40 patients with complex lesions treated with hybrid approach from February 2015 up to April 2017. Lesion segments with a large plaque burden and/or severe calcification, aorto-ostial and bifurcation lesions that may be unfavorable for BVS, treated with DES. BVS and DES were implanted with minimal overlap of DES and BVS struts. The primary end-point was target lesion failure (TLF) which was a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization (TLR). During follow-up, coronary angiography was performed when patients had ischemic symptoms.

NCT ID: NCT03570697 Completed - Clinical trials for Coronary Artery Disease (CAD)

Imaging of Coronary Plaques in Participants Treated With Evolocumab

Start date: November 19, 2018
Phase: Phase 3
Study type: Interventional

To evaluate the effect of evolocumab on fibrous cap thickness (FCT) in participants with non-ST-elevation acute coronary syndrome (NSTE-ACS) who are taking maximally tolerated statin therapy.

NCT ID: NCT03567733 Completed - Clinical trials for Coronary Artery Disease

Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents. Sierra 75 Study

SIERRA 75
Start date: June 18, 2018
Phase:
Study type: Observational [Patient Registry]

This prospective registry is intended to evaluate the safety and efficacy of the XIENCE Sierra stent.

NCT ID: NCT03567408 Not yet recruiting - Clinical trials for Coronary Heart Disease

Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)

Start date: September 15, 2018
Phase: Phase 2
Study type: Interventional

Bivalirudin is widely used as an anticoagulant to reduce the risk of bleeding in PCI perioperative period. Additionally, 15.7%-32.7% patients have diabetes mellitus who undergo percutaneous coronary interventions (PCI), so bivalirudin was used to anticoagulate in these patients to evaluate its safety and efficacy.

NCT ID: NCT03563989 Recruiting - Clinical trials for Coronary Artery Disease

STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion

SXS-CTO
Start date: June 26, 2018
Phase: N/A
Study type: Interventional

Intro: Chronic total occlusions (CTO) are the most severe coronary lesions. Negative distal vessel remodeling occurs in these lesions, leading to reduction of artery diameter. Treatment of CTO with percutaneous coronary intervention (PCI) is associated with good clinical outcomes. However, QCA and IVUS studies showed a notable lumen and vessel enlargement distal to recanalized CTO. In addition, optical tomography (OCT) studies showed high rates of stent strut malapposition and incomplete stent strut coverage after CTO PCI. The Stentys Xposition S is a self-apposing stent device which lowers stent strut malapposition rates. Its safety and effectiveness has been demonstrated in STEMI and stable coronary patients but never investigated in CTO lesions. Hypothesis/Objective To investigate whether self-expanding stents are more effective than balloon-expandable stents for reducing stent malapposition at 6 months after implantation in patients with CTO undergoing percutaneous coronary intervention. Method Pilot randomized study. Patients are randomized to receive either self-expandable stent or balloon expandable stent to perform CTO-PCI. Follow-up coronary angiography is performed at 6 months post-PCI. Stent malapposition is evaluated by OCT.

NCT ID: NCT03563768 Not yet recruiting - Clinical trials for Coronary Artery Disease

Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease

Start date: June 30, 2018
Phase: Phase 4
Study type: Interventional

The study is a prospective, randomized, controlled, exploratory trail to evaluate the strategy of "one-stop" endovascular treatment for concomitant coronary artery disease and aortic atherosclerotic disease.

NCT ID: NCT03563417 Recruiting - Clinical trials for Ischemic Heart Disease

ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO

ISCHEMIA-CTO
Start date: November 6, 2018
Phase: N/A
Study type: Interventional

Study design Prospective randomized open labeled multicenter study Hypotheses 1. In asymptomatic patients with ≥ 10% of myocardial ischemia: PCI (Percutaneous Coronary Intervention) with latest generation of drug eluting stents is superior to optimal medical therapy in terms of relative reduction in MACCE (Major Adverse Cardiovascular and Cerebrovascular events). 2. In symptomatic patients with ≥ 5% of myocardial ischemia: PCI with latest generation of drug eluting stents is superior to optimal medical therapy (OMT) in terms of improved life quality measured as an increase of SAQ (Self Assessment Questionnaire) score of 8 points after 6 months. Inclusion Criteria - CTO in native coronary artery - Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging. - Age ≥18 yrs. - Able to provide written Informed consent and willing to comply with the specified follow-up contacts - Target artery ≥ 2.5 mm Prior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into: Cohort A: Asymptomatic (CCS < 2 and SAQ QoL > 60) patients with myocardial ischemia (≥ 10% of LV) in a territory supplied by CTO Cohort B: Symptomatic patients (CCS class ≥ 2 and/or SAQ QoL score ≤ 60 after treating non CTO lesions and after OMT) with Myocardial ischemia (5% of LV) in a territory supplied a CTO Cohort C: patients enrolled but not randomized in cohort A or B Exclusion criteria (for both cohort A and B) - NSTEMI or STEMI within 1 month - Coronary anatomy not suitable for CTO-procedure - Coronary artery disease involving the left main/three-vessel disease with indication for CABG following heart team conference - Life expectancy < 2 years - Severe chronic pulmonary disease (FEV1 < 30 % of predicted value) - Contraindication to dual anti-platelet therapy - Pregnancy - eGFR < 30 mL/min/1.73 m2 - In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first. - Severe valvular heart disease Primary endpoint Cohort A: Composite endpoint of MACCE (all-cause mortality, stroke, any myocardial infarction, clinically driven revascularization*), hospitalization for heart failure or incidence of malignant arrhythmias. *CCS class ≥ 2 and/or QoL score < 60. Same criteria used as for allocation to Cohort B Cohort B: SAQ Quality of Life Assessment after 6 months. Number of patients 1,560 (1200 in cohort A/360 in cohort B Follow up time Cohort A: 5 years Cohort B: 6 months

NCT ID: NCT03555734 Active, not recruiting - Obesity Clinical Trials

Umbrella Review and Updated Systematic Review and Meta-analysis of Pulses/Legumes and Incident Cardiometabolic Diseases

Start date: November 21, 2017
Phase:
Study type: Observational

The European Association for the Study of Diabetes (EASD) guidelines have not made any specific recommendations regarding dietary pulses. To update the recommendations, the Diabetes and Nutrition Study Group (DNSG) of the EASD commissioned an umbrella review and updated systematic review and meta-analysis using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to summarize the available evidence from prospective cohort studies of the association between dietary pulses/legumes and cardiometabolic disease outcomes (incident cardiovascular diseases, diabetes, hypertension and overweight/obesity).

NCT ID: NCT03552432 Recruiting - Clinical trials for Coronary Artery Disease

The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography

ALTAIR
Start date: August 23, 2017
Phase: Phase 4
Study type: Interventional

the purpose of this study is to show that alirocumab with statin therapy have a s tronger stabilizing effect on vulnerable plaque in coronary artery disease than statin alone administration

NCT ID: NCT03551756 Recruiting - Clinical trials for Coronary Artery Disease

Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease

Start date: July 10, 2018
Phase:
Study type: Observational

Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease