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Myocardial Ischemia clinical trials

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NCT ID: NCT01489202 Not yet recruiting - Clinical trials for Coronary Artery Disease

Effects of DES Platforms on Markers of Endothelial Damage and Inflammation

PLATFORM
Start date: September 2014
Phase: Phase 4
Study type: Interventional

Percutaneous coronary intervention (PCI) with stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments. Drugs and polymers are considered the protagonists of these pathophysiologic processes whereas the role of stent platforms remains poorly defined.It remains unknown, conversely, if stent platforms affect the extent of post-PCI endothelial damage and inflammation.

NCT ID: NCT01469195 Not yet recruiting - Clinical trials for Coronary Artery Disease

A Lead Rectangle to Lower the Operator's Radiation Exposure

Start date: December 2011
Phase: N/A
Study type: Observational

During fluoroscopic imaging, diagnostic information is carried in the primary beam. These high intensity X-rays are the chief hazard to the patient. Lower energy scattered radiation deviates in all directions from the patient. Despite typical precautions (i.e., hanging a lead shield between the patient and the operator), many operators will be exposed to high radiation dose (higher than the permitted 50 miliS per year), this long term radiation exposure may result in stochastic and deterministic effects. The purpose of this study was to test the hypothesis that a non disposable radiation protection drape (that will cover the lower part of the patient) could help minimize the radiation scattered from the patient to the operator. In a procedure done through the Radial approach, there is a large portion of the patients (from the umbilicus and down) that is a source of scatter radiation to the operator. This portion can be covered with a lead rectangle. A non disposable, lead drape of uniform thickness will be inserted into a sterile nylon bag and will be used during fluoroscopic and cineangiography coronary angioplasty procedures. The lead drapes will cover the femoral puncture site. The widths and length of the drape is 50-60cm and 100 cm respectively and was shown not to hinder the field of radiation needed for fluoroscopy and cineangiography. (The upper border of the lead is under the patient's umbilicus and was shown not to interfere with the radiation field needed for angiography or angioplasty). The Investigators anticipate that the study will show a significant reduction in radiation exposure and hence reduce the radiation hazard to the operator.

NCT ID: NCT01399463 Not yet recruiting - Clinical trials for Coronary Artery Disease

Pressure-wire Guided PTCA: Drug Eluting Stent Versus Drug Eluting Balloon (WinDEB Study)

Start date: August 2011
Phase: N/A
Study type: Interventional

The aim of the study is to show the safety and efficacy of the SeQuent® Please (Drug Eluting Balloon or DEB) vs. commonly used Drug Eluting Stents in the treatment of small vessel disease and side branches by pressure wire guided percutaneous coronary intervention.

NCT ID: NCT01368991 Not yet recruiting - Clinical trials for Coronary Artery Disease

Clinical Trial of Kryptonite for Prevention of Sternal Complications in High Risk Patients Undergoing Cardiac Surgery

Kryptonite
Start date: July 2011
Phase: Phase 3
Study type: Interventional

Kryptonite is a non-toxic biologic polymer, that has previously been used in orthopedic surgery. The objective of our study is to demonstrate the benefits of Kryptonite in cardiac surgery patients at high risk for sternal wound complications. The investigators have designed a randomized clinical trial of 48 high risk patients, with a 1:2 randomization of kryptonite to conventional closure. The primary outcome will be quality of life. Secondary outcomes include sternal complications, pain, hospital length of stay, and respiratory function.

NCT ID: NCT01311323 Not yet recruiting - Clinical trials for Acute Coronary Syndrome

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

MILESTONE
Start date: January 2021
Phase: N/A
Study type: Interventional

MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary artery disease and/or with left main narrowing who present symptoms of acute ischemia. For such kind of patients according to current ACC/AHA guidelines CABG (surgical revascularization) is recommended as a treatment method. In comparison with CABG, recent studies have shown that PCI (percutaneous coronary intervention) is associated with a lower rate of periprocedural adverse events and similar long term event-free survival in patients with left main disease. Our latest non randomized registry and randomized LEMANS study, comparing LMCA (left main coronary artery) stenting with CABG confirmed above findings. LEMANS ACS (acute coronary syndrome) retrospective registry of patients with UPLMCA (unprotected LMCA) disease and non ST elevation ACS showed lower 30 day and trend toward lower one year mortality after PCI when compared with CABG. It should be stressed, that acute ischemia substantially increase the risk of CABG. In fact, there are limited data on the outcome of ULMCA stenting or CABG in patients with acute coronary syndromes (ACS). Similarly, all randomized studies comparing PCI vs CABG in multivessel disease included mainly patients with stable angina, small cohort of patients with unstable angina and they excluded patients with non ST elevation Myocardial infarction. In the SYNTAX study -largest PCI vs CABG trial, randomized patients were patients with low perioperative risk (logistic EUROSCORE <5) and ACS patients routinely excluded. High perioperative risk patients were included only in PCI registry.

NCT ID: NCT01233167 Not yet recruiting - Clinical trials for Coronary Artery Disease

Effect of Different Anti-platelet Strategies on the Long-term Outcome After Sirolimus Drug-eluting Stent Implantation

EASTS
Start date: August 2011
Phase: N/A
Study type: Interventional

The study aims to assess the effectiveness of dual antiplatelet therapy, aspirin alone versus steeply discontinued clopidogrel plus aspirin in preventing clinical MACE events.Our subject is beyond a 12-month period patients receiving sirolimus drug-eluting stent implantation.

NCT ID: NCT01171911 Not yet recruiting - Clinical trials for Coronary Artery Disease

Comparison of Intravenous Injection of Calcium Antagonist and Beta-blockade on Endothelial Shear Stress of Coronary Artery

Start date: October 2010
Phase: Phase 4
Study type: Interventional

Both calcium channel antagonist and beta-blocker have cardioprotective effect. Endothelial shear stress is predictive factor of clinical outcomes in patients with obstructive stenosis. The present study aims at comparing the re-distribution of shear stress and blood velocity during whole cardiac cycle after trans-coronary injection of Nicardipine and esmolol.

NCT ID: NCT01120327 Not yet recruiting - Clinical trials for Coronary Artery Disease

A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients

Start date: July 2010
Phase: Phase 4
Study type: Interventional

1. OBJECTIVES Primary objective to evaluate the difference of the peak oxygen uptake change (VO2 max, mL/kg/min) in amlodipine group against no CCB group at 9 months Secondary objectives To evaluate the change of sublingual nitrate use per day against no CCB group at 1 and 3 months To evaluate the change of biomarkers against no CCB group at 9 months 2. SUBJECTS AND CENTERS 212, stable angina patients with angiographically confirmed significant residual stenosis 10, 3rd-grade, teaching hospitals in Korea

NCT ID: NCT01106573 Not yet recruiting - Clinical trials for Coronary Artery Disease

Associations Between Diabetes, Arterial Stiffness and Fibulin-1 in Patients Undergoing Heart- and Vascular Surgery?

Start date: June 2010
Phase: N/A
Study type: Observational

Diabetes Mellitus (DM) is frequently appearing in patients with cardiovascular disease and these patients, as a consequence herby, has a lesser prognosis. DM is often related to increased arterial stiffness and hypertension. The investigators thesis is that DM and pre-diabetes is prevalent in patients undergoing cardiovascular surgery and to some extend is under-diagnosed. At the same time the investigators imagine that DM is closely related to the degree of arterial stiffness, and that these parameters are closely related to a new biochemical marker, fibulin-1. The investigators aim to describe the prevalence of type 2 DM and dysmetabolism in patients admitted to the hospital to undergo cardiovascular surgery and besides that to investigate if there is a connection between the degree of the dysmetabolism and arterial disease, by studying arterial stiffness and by measuring a new biochemical marker, fibulin-1, which the investigators newly have identified. The results of this project will give us a measure for the quantity of unknown DM in patients undergoing cardiovascular surgery and furthermore tell us more in terms of the connections between a newly identified plasma arterial marker, arterial stiffness and diabetes.

NCT ID: NCT01086163 Not yet recruiting - Clinical trials for Coronary Artery Disease

Effects of Omega-3 Fatty Acids on Platelets in Patients With Coronary Artery Disease With Hypertriglyceridemia

OMPA-CAD
Start date: October 2010
Phase: N/A
Study type: Observational

Omacor®/Lovaza® is an effective, and very safe mix of PO-3A, and the drug is currently approved by the Federal authorities for the drug management of post-infarction patients with high blood triglycerides. Given the growing length of CAD progression, it is pertinent that many more patients will yield extra benefit from Lovaza® on top of aggressive antiplatelet regimens and statin due to severity of their vascular disease. Therefore, mild antiplatelet properties of PO-3A will be a highly desirable and attractive commodity of this medication. The investigators believe that Omacor®/Lovaza® is ideally positioned for the chronic management of CAD as a safe, efficient, and "gentle" agent with no harmful interactions with statins or aspirin. The investigators hypothesize that addition of Omacor may add mild antiplatelet protection for CAD patients. The study objectives are: - To assess the ex vivo effects of Omacor® on platelet function in patients with coronary artery disease (CAD). - To compare ex vivo platelet-related effects after 7 and 14 days of therapy with Omacor and statin combination versus statin alone in patients with chronic stable coronary heart disease. - To establish the relation of changes in platelet activity (if any) with the lipid profile to prove an additional benefit of Omacor® on top of statin and aspirin.