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Infarction clinical trials

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NCT ID: NCT01398254 Completed - Clinical trials for Myocardial Infarction

Femoral Versus Radial Access for Primary PCI

SAFARI-STEMI
Start date: July 2011
Phase: N/A
Study type: Interventional

Primary percutaneous coronary intervention (PPCI) has become the dominant strategy for the treatment of ST-elevation myocardial infarction (STEMI), as studies have shown that PPCI is superior to fibrinolytic therapy. Recent evidence suggests that transradial access (TRA) is superior to transfemoral (TFA) for patients undergoing PPCI. Two large trials report a mortality benefit favouring TRA. The results of these two trials could significantly impact practice guidelines and lead to a recommendation that the approach of choice for primary PCI be radial rather than femoral. This would have significant implications for both PCI centers and interventionalists associated with a large impact on practice and education. Yet, many centers and interventionalists in Canada and in the USA prefer TFA and currently feel pressured in making the change to TRA. With that said, these trials did not include new pharmacotherapy and new technology that would likely have closed or eliminated the gap between TFA and TRA by improving the safety and efficacy of these two approaches. Furthermore, these trials were not powered to conclusively show a mortality benefit. The authors of the two large trials emphasized the need for further trials to confirm the benefits of TRA. The SAFARI-STEMI trial aims to compare TFA with TRA in patients undergoing primary percutaneous intervention (PPCI). The primary outcome will be defined as all cause mortality measured at 30 days. The trial will also evaluate: 1) bleeding events and 2) the composite of death, reinfarction, or stroke defined as major adverse clinical events (MACE). The trial will include the use of antithrombotic therapy with monotherapy, with either bivalirudin or unfractionated heparin; the use of glycoprotein inhibitors IIb/IIIa inhibitors will be avoided. The study will encourage liberal use of vascular closing devices. The trial will also compare delays to reperfusion between the two strategies. Finally, a cost analysis is proposed. In view of recent publications, there is now a need for a large randomized trial using contemporary adjunct therapies to assess the safety and efficacy of the TRA vs. the TFA in PPCI. The proposed trial aims to conclusively show whether there is a survival benefit associated with the TRA approach.

NCT ID: NCT01395303 Completed - Stroke Clinical Trials

Polymorphisms in the Vitamin D System and Health

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

Polymorphisms in the vitamin D system appear to affect the serum 25(OH)D levels. If so one would expect these polymorphisms to be associated with vitamin D related conditions and diseases, which will be tested in the present study including DNA analyses in 9700 subjects

NCT ID: NCT01395212 Completed - Clinical trials for Acute Myocardial Infarction

MYSTAR-5-YEAR: Long-term Follow-up of Patients With Ischemic Heart Disease Treated With Cell Therapy

MYSTAR-5-YEAR
Start date: July 2011
Phase: N/A
Study type: Observational

The MYSTAR-5-YEAR study controls the patients 5 years after treatment with combined (intramyocardial and intracoronary) delivery of autologous BM-MNCs. The clinical endpoint of this prospective non-randomized observational study is the MACCE, defined as major adverse cardiac and cerebrovascular events. Patients will be investigated by echocardiography, SPECT and MRI. 2D (NOGA-guided SPECT) and 3D (NOGA-guided MRI) imaging will refine the evaluation with more exact analysis of the intramyocardial injected areas (ROI).

NCT ID: NCT01392105 Completed - Clinical trials for Acute Myocardial Infarction

Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction

SEED-MSC
Start date: March 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Early reperfusion strategies in tandem with remarkable advances in drugs and devices for treating myocardial infarction (MI) have contributed to a reduction in early mortality, but cardiovascular disease remains the leading cause of death worldwide. Current management strategies cannot solve the problem of cardiomyocyte loss and consequent progression of heart failure. In this respect, stem-cell therapy has shown potential benefits for repairing the damaged myocardium. Mesenchymal stem cells (MSCs) have been considered to be attractive therapeutic candidates because of their high capacity for replication: paracrine effect: ability to preserve potency: and because they do not cause adverse reactions to allogeneic versus autologous transplants. Intracoronary injection of stem cells seems to be safe, but only one clinical trial using MSCs via the intracoronary route in the setting of acute myocardial infarction (AMI) has been carried out. The investigators therefore assessed the safety and efficacy of intracoronary autologous bone marrow (BM)-derived human MSCs in patients with AMI.

NCT ID: NCT01390142 Completed - Clinical trials for Myocardial Infarction

Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction

RIRE-1
Start date: July 2011
Phase: Phase 3
Study type: Interventional

RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis that remote ischemic preconditioning initiated at the time of the admission in the cathlab reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention (PCI). Furthermore, it will determine whether a combined approach remote ischemic preconditioning and local ischemic postconditioning can further reduce infarct size. Infarct size will be determined by cardiac magnetic resonance imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.

NCT ID: NCT01388504 Completed - Clinical trials for Acute ST Elevation Myocardial Infarction

Nitrites in Acute Myocardial Infarction

NIAMI
Start date: July 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The research question to be addressed is "Does a 2.5 - 5 minute systemic intravenous injection of sodium nitrite administered immediately before opening of the infarct related artery result in significant reduction of ischaemia reperfusion injury in patients with first acute ST elevation myocardial infarction (MI)?"

NCT ID: NCT01385631 Completed - Clinical trials for ST-Segment Elevation Myocardial Infarction

Ezetimibe In Addition To Atorvastatin Therapy On The Plaque Composition In Patients With Acute Myocardial Infarction.

OCTIVUS
Start date: June 2011
Phase: Phase 4
Study type: Interventional

The purpose of the study is to examine the effect of the cholesterol lowering agent Ezetimibe when used in addition to optimal treatment with Atorvastatin in patients with acute ST-Elevation Myocardial Infarction (STEMI) who have not been in prior statin therapy. An area with arteriosclerosis not demanding intervention in a coronary vessel other than the infarct related is used as measuring point and is examined at time of the infarction and after 12 month using intravascular ultrasound and optical coherence tomography. At the same time the same techniques are used to examine the implanted stent.

NCT ID: NCT01384019 Completed - Clinical trials for ST-segment Elevation Myocardial Infarction

Distal Protection Device in ST-elevation Myocardial Infarction (STEMI)

Start date: January 2004
Phase: Phase 4
Study type: Interventional

The investigators examined the mechanism underlying the lack of benefit from distal protection and thrombus aspiration (DP-TA) in 126 patients with ST-elevation Myocardial Infarction (STEMI) in a prospective, randomized trial.

NCT ID: NCT01382472 Completed - Clinical trials for ST Elevation (STEMI) Myocardial Infarction

Microcirculation In Acute Coronary Syndromes

MICROS
Start date: September 2011
Phase: Phase 4
Study type: Interventional

In this mechanistic pilot study in 40 patients the investigators will compare the findings in patients treated with very early high dose statin therapy with historic controls from the KOMPIS study published in EHJ 200925. The investigators want to assess if early high dose statin therapy in patients treated with primary PCI: 1. reduces area of myocardial infarction, reduces volumes and improves remodelling as assessed by MRI at 2 days and at 2 months 2. improves microcirculation (Decreased number of patients with MO) as assessed by first pass time estimated with MRI 2 days 3. have impact on coronary blood flow as assessed by intravascular registrations and TIMI frame count immediately after PCI 4. reduce levels of CK-MB and TnT measured as area under the curve during the hospital stay at improves neurohumoral profile assessed by Heart Rate Variability (HRV) and neurohormones at discharge and at 2 months follow-up 5. improves endothelial function assessed by flow mediated vasodilatation at discharge 6. alters Peak VO2 at 1 and 6 month 7. reduce levels of CRP and pro-inflammatory cytokines during index hospitalization and at follow-up alters collagen turnover

NCT ID: NCT01381185 Completed - Clinical trials for Acute Myocardial Infarction

REsistance to Aspirin and Clopidogrel in acuTe Myocardial Infarction

REACT-MI
Start date: May 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare 3 point-of-care methods for monitoring antiplatelet therapy to golden standard (Light transmittance aggregometry-LTA) in high risk population of acute myocardial infarction patients. If two methods (PFA-100, VerifyNOW,Multiplate or LTA) will indicate insufficient antiplatelet blockade/high residual reactivity for aspirin, clopidogrel or both, the dose of aspirin will be increased to 200mg qd and the dose of clopidogrel will be increased to 2x75mg qd.In addition genotyping of CYP2C19 (6 alleles) will be performed.