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Coronary Artery Disease clinical trials

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NCT ID: NCT00481234 Completed - Anesthesia Clinical Trials

Heart Rate Variability for Prediction of Perioperative Events

Start date: June 2002
Phase: N/A
Study type: Observational

Patients with underlying cardiovascular disease are at high risk of perioperative cardiovascular events and death. Hemodynamic variables are controlled by the autonomic nervous system reflected by Heart Rate Variability. To investigate whether differences of HRV parameters predict perioperative cardiovascular events.

NCT ID: NCT00479986 Completed - Clinical trials for Type 2 Diabetes Mellitus

Effects of Pioglitazone in Type 2 Diabetes Mellitus and Coronary Heart Disease

PIOcard
Start date: June 2005
Phase: Phase 4
Study type: Interventional

The goal of the study is to investigate the impact of a 4 week treatment with pioglitazone (in comparison to placebo) on biomarkers for atherosclerosis and cardiovascular risk, as well as the degree of activation of the immune system, when given on top of an anti-diabetic treatment (metformin and/or sulfonylurea drugs) that has already resulted in good glycemic control.

NCT ID: NCT00477737 Completed - Clinical trials for Coronary Artery Disease

Early Cardioprotective Effect of Sevoflurane

Start date: August 2006
Phase: Phase 4
Study type: Interventional

In vitro studies and in vivo animal experiments have shown that halogenated volatile anesthetics have a protective effect on the ischemic myocardium. In clinical settings however, anesthetic preconditioning may be of more interest. The aim of our study was to evaluate the cardioprotective effect of sevoflurane in patients undergoing off-pump coronary artery bypass surgery. We proposed that a cardioprotective effect of sevoflurane would save myocardial function, which we measured acceleration by esophageal Doppler and cardiac index with bolus thermodilution methods, both during brief ischemia and reperfusion.

NCT ID: NCT00476957 Completed - Clinical trials for Ischemic Heart Disease

Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)

PROTECT
Start date: June 2007
Phase: Phase 4
Study type: Interventional

The PROTECT TRIAL is a randomized stent trial with 8800 patients in approximately 200 hospitals, which is designed to evaluate whether the Endeavor stent PROTECTS against late stent thrombosis resulting in less deaths and myocardial infarctions. Study Stents: Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System or next generation model Cordis Cypher® Sirolimus-eluting Coronary Stent, Cordis Cypher Select® Sirolimus-eluting Coronary Stent or next generation model Primary Objective: To compare overall stent thrombosis rate of the Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation Secondary Objective: To compare the composite endpoint of total death or cardiac death combined with the number of patients with all non-fatal myocardial infarctions as well as the number of patients with large non-fatal myocardial infarctions for Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation. To assess the safety and efficacy in patient subgroups with specific demographics, clinical indications and/or vessel- or lesion characteristics.

NCT ID: NCT00476944 Recruiting - Clinical trials for Coronary Artery Disease

Comparing Bivalirudin Versus Heparin/ GP IIB/IIA in Patients Undergoing PCI

Start date: September 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the rates of vascular related complications in patients undergoing percutaneous coronary intervention assigned to one of two arms: 1) bivalirudin + provisional Gp IIB/IIIA use versus 2) heparin + Gp IIB/IIIA (eptifibatide (Integrilin®)) use.

NCT ID: NCT00475488 Active, not recruiting - Clinical trials for Coronary Artery Disease

Radial Artery Patency and Clinical Outcomes Trial

RAPCO
Start date: June 1996
Phase: N/A
Study type: Interventional

Coronary Artery Bypass Graft (CABG)Surgery is commonly used to treat patients with coronary artery disease (atherosclerosis) for the relief of angina (chest pain) and improve heart muscle function. Healthy veins or arteries, referred to as 'conduits' from elsewhere in the patient's body, are grafted (attached) from the aorta to the coronary arteries, bypassing (via new routes) coronary artery narrowings caused by atherosclerosis (hardening of the arteries) and thereby improving the blood supply to the myocardium (heart muscle). Over the years, a range of different veins and arteries from around the body have been used to bypass diseased coronary arteries. Typically, internal thoracic arteries from behind the breastbone and the saphenous veins from the legs are used for bypass. More recently, radial arteries from the forearm have also been used to bypass coronary arteries that are diseased (atherosclerotic). There is strong evidence to indicate that the left internal thoracic artery stays open the longest (i.e. has the highest patency) and achieves the best health outcomes. As a result, most cardiac surgeons use the left internal thoracic artery as their first choice of conduit (vessel used to bypass the blocked artery). However, many patients require multiple grafts and there is little evidence as to which grafts are the best conduits to use. It has been suggested that the radial arteries might function better than saphenous veins as conduits. The Radial Artery Patency and Clinical Outcomes Trial(RAPCO) aims to compare patency of the radial arteries with the right internal thoracic artery and also with the saphenous vein.

NCT ID: NCT00475449 Completed - Clinical trials for Coronary Artery Disease

The Stent or Surgery (SoS) Trial

Start date: November 1996
Phase: N/A
Study type: Interventional

This study compared two different methods of restoring blood flow to the heart when there has been a narrowing or blockage in the blood vessels that supply the heart. Currently there are two different ways of restoring blood flow. One is heart surgery where a surgeon operates directly on the heart, through an incision in the breast bone (sternum) and takes segments of the patient’s (non-essential) veins or arteries and then uses these to bypass blocked or narrowed segments in the coronary arteries. This way additional blood can be “piped” into the heart muscle wall. The second method is coronary angioplasty with stent implantation. Coronary angioplasty is a non-surgical method performed under a local anaesthetic. During angioplasty a special balloon is advanced to the site of a coronary narrowing, then inflated to make it expand and this action removes the narrowing. This is a more simple and less invasive than surgery but its value has been limited by a tendency for narrowings to reoccur(restenosis) in the six months following the treatment. When this happens a repeat procedure is often performed. To reduce the incidence of restenosis coronary stents are implanted. These are tubular metal scaffold devices that are placed inside a coronary artery at the site of a previous narrowing to help keep the artery open. These devices are usually delivered on an angioplasty balloon and expanded into place. Both treatments are equally effective at preventing death and subsequent myocardial infarction and most doctors are happy to recommend either option. Angioplasty offers a more simple initial procedure but with a chance of needing a repeat performance. Bypass surgery represents a more significant initial undertaking with a longer recovery and convalescent period but in most cases, provides good relief of symptoms. Patient preference plays an important part in the decision process. Bypass grafting is currently the therapy most frequently performed world-wide. Angioplasty has a number of important advantages but the need for repeat procedures currently limits its appeal. Since these trials were performed there have been important advances in angioplasty techniques. Prominent amongst these has been the development and use of Coronary Stents which has been shown (in clinical trials) to reduce the need for repeat procedures after an initial angioplasty. Consequently stent implantation is now in routine use world wide. If angioplasty is performed with coronary stent implantation then this may reduce the need for repeat procedures and address the principal factor currently limiting the value of this approach. If the results were found to be as good as with bypass grafting then patients could benefit from a shorter hospital stay, a less traumatic operation and a shorter recovery period. We therefore wish to compare the outcomes in patients treated with a) bypass grafting or b) angioplasty with coronary stent implantation.

NCT ID: NCT00474565 Withdrawn - Clinical trials for Coronary Artery Disease

Coronary Artery and Coronary Artery Bypass Graft Imaging Using a Specialized Catheter and Computed Tomography

Start date: February 2007
Phase: Phase 1
Study type: Interventional

The present study relates to a new approach to coronary artery and coronary artery by-pass graft imaging, and more particularly to computed tomographic angiography following an aortic root injection of a low amount of contrast (up to 30 cc) via a percutaneously placed catheter (Vanguard DX, Medrad Inc.) positioned in the aortic root. The objective of the study is to show the feasibility of Coronary artery CTA using aortic root injection of contrast compared to the standard invasive cardiac catheterization.

NCT ID: NCT00474461 Completed - Clinical trials for Coronary Artery Disease

Cardiac Stem Cell Infusion in Patients With Ischemic CardiOmyopathy (SCIPIO)

SCIPIO
Start date: February 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety of intracoronary cardiac stem cells (CSCs) therapy in humans. Currently, there is no effective intervention to regenerate (regrow) dead heart muscle after a heart attack. The central hypothesis is that CSCs infused into nonviable myocardial segments will regenerate infarcted myocardium by differentiating into cardiomyocytes and other cell types. According to our hypothesis, CSC infusion regenerates myocardium with consequent improvement in contractile function of the heart and general clinical status.

NCT ID: NCT00474084 Not yet recruiting - Clinical trials for Coronary Artery Disease

Hydroxyapatite Active Pro Healing Clinical Trial Program

HApFIM
Start date: July 2007
Phase: N/A
Study type: Interventional

The purpose of this first feasibility study is to evaluate the performance of Vesta™ & VestaCOR™ (Hydroxy-Apetite coated GenX) stent in de novo native coronary artery lesions. This study will provide the longest follow-up experience available. This is a randomized, double blind study conducted at three sites, two sites in India and one in The Netherlands. To be eligible, a patient will be required to have a de novo stenotic lesion of a length that could be covered by a single stent in a native coronary artery of diameter 3.0mm and 3.5mm. A total of at least 60 patients and a maximum of 70 patients will be treated with Vesta™ & VestaCOR™ stent. These patients will be randomized to either a smooth surface nanofilm coated stent (= VestaCOR™) (approx. 35 patients) or to a porous coated stent (= Vesta™) (approx. 35 patients). All patients will be followed clinically at 30 days, 4 months, 9 months, 1, 2, 3, 4 and 5 years.