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Coronary Artery Disease clinical trials

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NCT ID: NCT01200693 Completed - Clinical trials for Coronary Artery Disease

Z-SEA-SIDE: Sirolimus Versus Everolimus Versus Zotarolimus-eluting Stent Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis

Z-SEA-SIDE
Start date: November 2008
Phase: Phase 4
Study type: Interventional

BACKGROUND: Bifurcated lesions are a challenging subset in percutaneous coronary interventions (PCI). The selection of the type of drug-eluting stents (DES) and the technique for stent implantation have not been clarified. The side-branch (SB) is emerging as critical point, accounting for more than a third of the significant restenosis in the DES era. A series of data supports the adoption of a conservative strategy: stenting the main vessel (MV) only and reserving a conservative approach on the SB. Yet, the clinical relevance in terms of inducible ischemia of sub-optimal angiographic result has not been clarified. AIMS OF THE STUDY: The aims of the present study are: 1. to compare in a prospective study the acute 3D angiographic results and the late clinical outcome of Sirolimus-eluting (SES) vs Everolimus-eluting (EES) vs Zotarolimus eluting stent (ZES) obtained using a provisional TAP-stenting technique. 2. to prospectively assess the clinical relevance (inducible ischemia) of suboptimal angiographic result in the SB after stenting. METHODS TO BE APPLIED: 75 consecutive patients with bifurcated lesions undergoing PCI with the provisional T-and-small-protruding (TAP) technique with ZES implantation will be enrolled. Procedural and post-PCI details will be prospectively recorded. The subgroup of patients in which complete revascularization has been achieved will enter a systematic assessment of inducible ischemia by early and late exercise tests. Off line 3D quantitative coronary angiography (QCA) assessment will be performed and used to divide the study population in 2 groups according to the SB residual stenosis: - Group O (optimal SB angiographic result): post-PCI SB area stenosis<50% - Group S (sub-optimal SB angiographic result): post-PCI SB area stenosis>50%. For the comparison among SES and EES, data will be obtained from the randomized trial SEA-SIDE (NCT00697372). PRIMARY STUDY END-POINTS. 1. COMPARISON BETWEEN ZES, SES AND EES: SB acute angiographic result; SB trouble; target bifurcation failure. 2. SB-RELATED ISCHAEMIA of Group O vs Group S in patients with complete revascularization: inducible ischemia at the early exercise test or occurrence of early spontaneous ischemia related to the SB.

NCT ID: NCT01200056 Completed - Coronary Disease Clinical Trials

Virtual Histology Findings and Effects of Varying Doses of Atorvastatin Treatment

VENUS
Start date: August 2007
Phase: Phase 4
Study type: Interventional

While statin treatment may induce plaque regression, the effect of statin on plaque composition with varying doses is unknown. This study assessed such effects by volumetric virtual histology intravascular ultrasound (VH-IVUS). In this prospective, randomized, double-blinded pilot study, statin-naïve patients with stable angina requiring percutaneous coronary intervention (PCI) were randomized to receive 6 months of either atorvastatin 10mg or 40 mg daily. VH-IVUS was performed in all non-PCI lesions at baseline and 6 months; all analyses were performed by core laboratory.

NCT ID: NCT01199419 Completed - Clinical trials for Multivessel Coronary Artery Disease

Cost-effectiveness of PCI With Taxus vs CABG - 5 Years FUP

Start date: January 2004
Phase: N/A
Study type: Observational

The objective of the present study is to analyze the cost-effectiveness of percutaneous coronary intervention (PCI) using TAXUS stents compared to the costs of coronary artery bypass surgery (CABG) in patients with multivessel coronary artery disease (CAD) in the first 5 years and then 10 years after intervention. Multivessel PCI or CABG was performed in 114 or 93 patients, respectively. Clinical outcomes, in terms of incidence of acute myocardial infarction (AMI), all-cause death, target vessel revascularization (TVR) and stroke, resource use and costs are analyzed prospectively over a 5 and 10-year follow-up (FUP) period. Overall costs consist of the baseline costs of the index procedure (PCI or CABG), clinical and angiographic procedure-related treatments during the entire FUP. The primary endpoint is cost-effectiveness and clinical effectiveness, defined as the reduction of the composite of major adverse cardiac and cerebrovascular events (MACCE).

NCT ID: NCT01196819 Completed - Clinical trials for Coronary Artery Disease

Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial

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

The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.

NCT ID: NCT01196273 Completed - Heart Failure Clinical Trials

Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 5 Years Follow-up

Start date: December 2009
Phase: N/A
Study type: Observational

HIV-infection is associated not only with a reduced function of the immune system, but also linked with diseases of other organ systems, in particular with the heart. Heart conditions that have been described with HIV include - Pericarditis, - Pleural effusion - Pulmonary hypertension (Venedic classification typ II) - Dilated cardiomyopathy - Heart failure - Myocarditis - Bacterial endocarditis - Heart valve disorders In addition to previously stated disorders of the heart, the premature atherosclerosis of coronary arteries, a further even more important disease of the heart in this patient population, went into the focus of most HIV-researchers and physicians. Premature atherosclerosis of coronary arteries results in coronary calcification, angina pectoris, myocardial infarction and sudden death. HIV-positive patients are at greater risk for a variety of heart-related conditions, including coronary artery disease. It is assumed, that HIV infection doubles the risk of a heart attack, according to recent research. The reason for this link between HIV and heart-related conditions is unknown, but secondary infections that affect the heart muscle and coronary arteries have a greater chance of occurring in people with compromised immune systems. In addition, the HI-virus itself had been detected in the myocardium and might have an impact on the premature of cardiovascular diseases. Furthermore, some of the medications used to treat HIV patients (antiretroviral therapy, ART) are assumed to have heart-related side effects. Therefore, current treatment regimens for HIV infection have to be balanced against the marked benefits of antiretroviral treatment. Nevertheless, prevention of coronary heart disease should be integrated into current treatment procedures of HIV-infected patients. The link between the heart and HIV is well established but not well understood. Therefore, further results are needed for efficient guidelines for the prevention, diagnostic and therapy of HIV-associated cardiovascular diseases.

NCT ID: NCT01192724 Completed - Clinical trials for Coronary Artery Disease

Additional Benefit of Cilostazol to Dual Antiplatelet Therapy After Biolimus-eluting Stent Implantation

ABCD
Start date: March 2010
Phase: Phase 4
Study type: Interventional

Because there is limited data about long-term efficacy and safety about short-term use of cilostazol adding to dual antiplatelet therapy in patients with long or multivessel coronary artery disease after 2nd generation DES implantation, especially in biodegradable polymer stent, the investigators will evaluate whether a 3-month use of cilostazol in addition to dual antiplatelet therapy effectively reduces clinical adverse outcome at 1 year in subject with long or multivessel coronary artery disease after biolimus-eluting stent implantation.

NCT ID: NCT01190904 Completed - Clinical trials for Coronary Artery Disease

Hormones and Sexual Function Predict Outcomes in Revascularized Men With Diabetes

HEART-MEND
Start date: January 2010
Phase: N/A
Study type: Observational

The purpose of this study is to find out if androgen deficiency (low levels of testosterone, a male hormone produced by the sex glands) and erectile dysfunction (sexual dysfunction) will predict over time the development of a heart attack, stroke, or death in men with Diabetes Mellitus who have angiographically proven coronary artery disease (CAD) (≥50%) with or without percutaneous coronary intervention (PCI). A substudy aims to show the different factors and processes that may show a relationship between sexual function and levels of androgen in the body to heart disease.

NCT ID: NCT01189331 Completed - Clinical trials for Coronary Artery Disease

CT Coronary Angiography and Computational Fluid Dynamics

Start date: October 13, 2009
Phase: N/A
Study type: Interventional

Angiographically obtained fractional flow reserve(FFR) could provide functional and clinical information about stenotic lesion, but the invasiveness and measuring difficulty of FFR make it unfamiliar to perform. CT coronary angiography is non-invasive tool to evaluate lesion severity and lately developing computational fluid dynamics could provide functional information. The investigators build a patient specific model of computational fluid dynamics by CT coronary angiography and evaluate the functional significance by measuring fractional flow reserve via CT coronary angiography and computational fluid dynamics, and investigate its long-term prognostic implications.

NCT ID: NCT01186666 Completed - Clinical trials for Coronary Artery Disease

Imaging and Biomarkers of Atherosclerosis in Patients With Stable or Unstable Coronary Artery Disease

BIOCORE-2
Start date: February 2010
Phase: N/A
Study type: Interventional

In this study, multimodal imaging of atherosclerosis and dosage of new circulating biomarkers will be used to compare patients with stable or unstable coronary artery disease

NCT ID: NCT01186198 Completed - Clinical trials for Ischemic Heart Disease

A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions

CROSS
Start date: August 12, 2010
Phase:
Study type: Observational

This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions.