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STEMI clinical trials

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NCT ID: NCT03622203 Completed - Coronary Disease Clinical Trials

Outcome of CHAllenging lesioNs and Patients Treated With Polymer Free Drug-CoatEd Stent

CHANCE
Start date: January 1, 2016
Phase:
Study type: Observational [Patient Registry]

Length of DAT (Dual Antiplatelet therapy) represents one of the most challenging choices for interventional cardiologist. Prolonged DAT reduces risk of subsequent MI (Myocardial Infarction) with an increase in major bleedings, consequently with a neutral effect on survival [1]. Recently a Polymer-free Drug-Coated coronary stent has been tested in a randomized controlled trial with only one month of DAT due to its peculiar features, with an increased efficacy compared to BMS (Bare Metal Stent) and with a not negligible risk of ST at one year (about 2%)[2,3]. The RCT despite its promising design (inclusion of high risk patients like those with previous bleeding or with severe renal disease) showed a major limitation, that is: 1. patients who are often offered a Biofreedom in real life, that is those with active cancer or needing major surgery or on OAT (Oral Anticoagulation) 2. and patients with bifurcation and multivessel disease, that is those with an increased risk of ST [4] 3. STEMI patients [5] were underrepresented (less than 30%). Consequently we performed this multicenter study to evaluate safety and efficacy of Biofreedom in real life patients. POCE (a composite end point of death, myocardial infarction, target lesion revascularization) and DOCE (cardiac death, MI-TLR and TLR) will be the primary end points, while its single components will be the secondary ones along stent thrombosis and with bleedings (Barc classification). At least 12 months The Leaders FREE (2) reported an incidence of MACE of 9.4% at one year in overall patients. If there is a true difference in favour of the experimental treatment of 1.2%, then 870 patients are required to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference when compared to non selected patients of more than 2% [5] All patients implanting Biofreedom with these prespecified analysis: 1. Clinical - Diabetic patients (both insulin and not insulin depenent) - Requiring oral anticoagulation - On active cancer (that is requiring chemio or radio-therapy and or surgery) - Requiring surgery - STEMI 2. Interventional - Bifurcation (both provisional both 2 stents) - Multivessel - Ostial

NCT ID: NCT03507777 Completed - Clinical trials for Coronary Artery Disease

ILUMIEN IV: OPTIMAL PCI

Start date: May 17, 2018
Phase: N/A
Study type: Interventional

The objective of this prospective, single-blind clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.

NCT ID: NCT03470441 Completed - Clinical trials for Acute Myocardial Infarction

A Study of Acute Myocardial Infarction Using FDY-5301

Start date: October 27, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.

NCT ID: NCT03461484 Completed - Ischemia Clinical Trials

e-BioMatrix 6 Month DAPT France

Start date: March 6, 2014
Phase:
Study type: Observational [Patient Registry]

Prospective, multi-center observational study to be conducted in up to 30 French interventional cardiology centers. The purpose of this observational study is to capture, in French Centers, clinical data of the BioMatrix Flex™ and BioMatrix NeoFlex™ Drug Eluting Coronary Stents System (Biolimus A9, BA9™-) in normal practice, in patients treated with 6-month DAPT, and to compare the outcomes to those of previous e-biomatrix registries with longer DAPT durations. The patients will be followed up for 2 years for data collection.

NCT ID: NCT03400267 Completed - STEMI Clinical Trials

The Effect of Opioids on P2Y12 Receptor Inhibition in Patients With ST-Elevation Myocardial Infarction Who Are Pre-treated With Crushed Ticagrelor

ON-TIME 3
Start date: February 16, 2018
Phase: Phase 4
Study type: Interventional

Fast and accurate platelet inhibition is an important therapeutic goal in the acute treatment of patients with ST-segment elevation myocardial infarction (STEMI). Platelet inhibitory effects induced by normal oral P2Y12 receptor antagonists, for example ticagrelor, are delayed in STEMI patients undergoing primary percutaneous coronary intervention (primary PCI), which may be attributed to impaired absorption affecting drug pharmacokinetics (PK) and pharmacodynamics (PD). Another therapeutic goal in the acute treatment of STEMI is reduction of sympathetic stress and catecholamine release, thereby improving the balance between the demand for and supply of oxygen, by analgesia like fentanyl of morphine. To date, there are no studies that have specifically assessed the pharmacodynamics influences of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor tablets. Therefore, In the ON-TIME-3 study, the investigators seek to show the influence of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor in the ambulance.

NCT ID: NCT03312179 Completed - Clinical trials for Coronary Artery Disease

STEMI and Incretins Treatment

Start date: January 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

ST elevation myocardial infarction (STEMI) patients affected by multivessels coronary artery stenosis, represent a clinical relevant problem. The management and prognosis of these patents are supported by few literature data. Therefore, in this study authors enrolled real world diabetic vs. non diabetic patients admitted for STEMI and associated to multi vessels coronary disease. Then these diabetics were divided in incretin users (6 months of incretin treatment before study enrollment) vs. never incretin users. In these patients authors studied all cause mortality, cardiac mortality, and major adverse cardiac events at 12 months follow up.

NCT ID: NCT03103620 Completed - Clinical trials for Myocardial Infarction

Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry

eCOBRA
Start date: September 10, 2015
Phase:
Study type: Observational

A multi-center, prospective, consecutive enrolled, observational registry. The population being studied includes all patients undergoing treatment of "de novo" lesions in native coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF coronary stent system. The registry will primarily assess the rate of MACE (cardiac death, myocardial infarction and clinically driven target lesion revascularization.

NCT ID: NCT03037229 Completed - STEMI Clinical Trials

Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction

ST LEUIS
Start date: December 29, 2016
Phase:
Study type: Observational

Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in the identification of STEMI (ST Elevation Myocardial Infarction).

NCT ID: NCT03000270 Completed - STEMI Clinical Trials

Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study

DTU
Start date: April 11, 2017
Phase: N/A
Study type: Interventional

Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible

NCT ID: NCT02982057 Completed - STEMI Clinical Trials

Non Culprit Lesion Study

Start date: January 2015
Phase: Phase 3
Study type: Interventional

The aim of the present study is to compare the evolution of non culprit lesions after treatment by BVS versus optimal medical therapy at 2-years follow- up