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No-Reflow Phenomenon clinical trials

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NCT ID: NCT06342141 Not yet recruiting - STEMI Clinical Trials

Empagliflozin for No-reflow Phenomenon in PCI for STEMI

EMPA-PCI
Start date: May 15, 2024
Phase: Phase 2
Study type: Interventional

Myocardial infarction remains, in our current era, a leading cause of morbidity and mortality both domestically and globally. A significant contributor to this issue is reperfusion injury, which enlarges the infarction, deteriorates ventricular function, leads to poorer outcomes, and currently has no specific treatment. Originally developed as an antidiabetic, empagliflozin has shown significant benefits in other organs and systems. Recent years have seen the demonstration of its cellular and vascular effects in animal models, potentially contributing to the reduction of reperfusion damage. However, no human studies have yet confirmed these effects. Consequently, this double-blind, randomized, parallel-arm clinical trial was designed to evaluate the effect of empagliflozin treatment, administered from the pre-intervention period through to 3 days post-intervention, on the incidence of the no-reflow phenomenon in patients with ST-segment elevation myocardial infarction (STEMI) undergoing coronary angioplasty compared to a placebo. Before entering the hemodynamics room, participants in the intervention group will receive a loading dose of 25 mg of empagliflozin or a placebo. In-hospital treatment will continue with 10 mg empagliflozin daily for 3 days for the intervention group, while the control group will receive a placebo. Patients will be monitored weekly during the first month and bi-weekly during the second and third months. The primary outcome will be the incidence of the no-reflow phenomenon, measured through the Thrombolysis in Myocardial infarction (TIMI) flow scale in the coronary angiography performed to treat the infarction. Secondary outcomes will include the reduction of ST segment on the electrocardiogram, troponin levels, differences in the longitudinal strain by echocardiogram, and infarct size by magnetic resonance imaging.

NCT ID: NCT05427786 Recruiting - Clinical trials for Coronary Artery Disease

A Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT reductioN Of decREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease

Start date: December 14, 2022
Phase: Phase 4
Study type: Interventional

The aim of this study was to determine the effect of intra-coronary administration of nicorandil on the prevention of lowering of coronary blood flow for high-risk plaque lesions defined as the high value of lipid core burden index in patients with coronary artery disease who require stent treatment.

NCT ID: NCT05393557 Not yet recruiting - STEMI Clinical Trials

Upfront Premedication For Reduction of Microvascular Obstruction and No-reflow in Treating ST-segment Elevation Myocardial Infarction

UPFRONT-STEMI
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Angiographic no-reflow during primary PCI procedures occurs at relatively high rate (25%) and is associated with worsening of long term morbidity and mortality. The exact mechanism of no-reflow is not fully understood, yet it is believed to be multifactorial including microvascular plugging with activated platelets and thrombotic debris in addition to the microvascular dysfunction from the ischaemia-reperfusion injury. Despite a theoretical advantage of glycoprotein IIb/IIIa inhibitors (GPi) (like; Tirofiban) to suppress the intense platelets' activation/reaction; their use did not lead to a significant net benefit, because it was opposed by increased risk of bleeding. However, the bleeding that plagued GPi use was predominantly related to vascular access in the era femoral approach was the default. Moreover, there are some recent data suggesting that small intracoronary bolus of GPi was non-inferior to intravenous bolus-infusion dose with less bleeding events. This study plans to assess upfront premedication with small doses of GPi + Nitroglycerin ± Verapamil, with staged restoration of flow (repeated balloon inflation) to reduce angiographic no-reflow and CMR assessed microvascular occlusion (MVO).

NCT ID: NCT05360602 Not yet recruiting - Clinical trials for No-Reflow Phenomenon

Alpha Lipoic Acid Effect on No-Reflow Phenomenon

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Prospective, randomized, open-label, controlled clinical trial to evaluate the efficacy and tolerability of Alpha Lipoic Acid administration on oxidative stress, inflammatory markers, clinical outcome and occurrence of No-Reflow in post myocardial infarction (MI) patients by assessment of aldehyde dehydrogenase-2 (ALDH2) as a marker of oxidative stress and paraoxonase-1 (PON-1) as a marker of oxidative stress and inflammation.

NCT ID: NCT05355532 Completed - Clinical trials for Myocardial Infarction

Genetic Determinants of the Coronary Microvascular Obstruction in PCI

Start date: April 11, 2022
Phase:
Study type: Observational

Myocardial infarction (MI) remains one of the most common causes of death. Percutaneous coronary intervention (PCI) is the main treatment option to restore blood flow through the infarction-related coronary artery (IRA) in MI patients. Performing PCI significantly reduces mortality, but in 5-10% cases, PCI is complicated by the development of coronary microvascular obstruction (CMVO, "no-reflow"). CMVO is defined as the absence of adequate myocardial perfusion, despite the restoration of the IRA lumen. The development of CMVO significantly worsens the prognosis and increases mortality. CMVO has a complex pathogenesis and is development due to following mechanisms: distal microembolism, ischemia-reperfusion injury, persistent endothelial dysfunction, and individual predisposition. These mechanisms can be implemented simultaneously and have different severity. The most significant predictors of CMVO occurrence are: age, time from pain onset to reperfusion, severity of acute heart failure, ineffective thrombolytic therapy, collateral blood flow according to the Rentrop classification, severity of IRA thrombosis according to Thrombolysis in Myocardial Infarction (TIMI) thrombus grade, initial IRA blood flow according to TIMI flow grade, implantation of 3 or more stents, direct IRA stenting, neutrophil and blood glucose levels. Difficulties in CMVO predicting are caused by the pathogenetic heterogeneity of this complication. Even the best models are moderately accurate. This can be explained by the fact that the models don't use genetic factors that determine endothelial function, microcirculation, hemostasis, and inflammation. Identification of the genetic determinants of the CMVO development can help create a new diagnostic system for CMVO predicting.

NCT ID: NCT04835974 Not yet recruiting - Clinical trials for No-Reflow Phenomenon

the No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI)

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

1- to find metabolic factors that correlate with the development of no reflow phenomenon that may help prevent its occurrence .

NCT ID: NCT04785209 Completed - Clinical trials for No-Reflow Phenomenon

Mean Platelet Volume and STEMI Clinical Risk Scores in Prediction of Impaired Myocardial Perfusion In Acute STEMI Patients Undergoing Primary Percutaneous Coronary Intervention.

Start date: September 1, 2020
Phase:
Study type: Observational

Predicting no reflow in ppci of STEMI patients using mean platelet volume together with STEMI clinical risk scores

NCT ID: NCT04699110 Completed - Clinical trials for Acute Coronary Syndrome

Adrenaline for the Treatment of No-Reflow in Normotensive Patients

Start date: January 1, 2021
Phase: Phase 4
Study type: Interventional

No-reflow is defined as the lack of myocardial perfusion despite opening of the epicardial coronary vessels in the setting of percutaneous coronary intervention (PCI). It has been demonstrated that either impaired flow or the absence of flow is associated with an increased rate of mortality. Among available treatment options, intracoronary adenosine is widely used in clinical practice, moreover, adrenaline is a safe alternative for the cases where use of adenosine is limited due to presence of hypotension or bradycardia. Nonetheless, evidence from retrospective and observational studies suggest that intracoronary adrenaline is well tolerated and may exert encouraging effects in prompt recovery of flow in these patients. However, very limited data are available on efficacy of intracoronary (IC) adrenaline in normotensive patients. Therefore, this study is planned to study the hypothesis that; intracoronary adrenaline is safe and has significantly higher efficacy as compared to adenosine for the treatment of no-reflow in normotensive patients with acute coronary syndrome.

NCT ID: NCT04573751 Completed - Clinical trials for Percutaneous Coronary Intervention

The EPIVER Randomized Controlled Trial

EPIVER
Start date: December 30, 2020
Phase: N/A
Study type: Interventional

The trial aims to estimate the efficacy and safety of the intracoronary administration of adrenalin, verapamil, as well as their combination compared to standard treatment in patients with STEMI and refractory coronary no-reflow despite conventional treatment during percutaneous coronary intervention (PPCI)

NCT ID: NCT04017169 Completed - STEMI Clinical Trials

No Reflow Phenomenon Incidence and Predictors

NORM-PPCI
Start date: October 29, 2015
Phase:
Study type: Observational

Background No reflow phenomenon is described in up to 65% of patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction (STEMI). It is known to be associated with worse outcomes but predictors of no reflow are not clearly described. Objectives A single centre case-control observational study of patients presenting with acute myocardial infarction appropriate for PPCI comparing baseline clinical, biochemical and angiographic characteristics between patients with no reflow phenomenon and those without. Aiming to establish incidence for the UK population. Secondary outcomes will be to gain further insight into those presenting with STEMI for PPCI and develop a risk model to guide management and clinical outcomes of patients to 30days. Methods This study will prospectively recruit all consecutive patients attending a single centre for primary percutaneous coronary intervention for STEMI. Angiographic assessment of the recanalised epicardial vessel will be used to diagnose no reflow (reduced TIMI flow or blush grade). Baseline demographic, angiographic and biochemical characteristics and outcomes at 30days for reflow and no reflow cohorts will be statistically assessed and compared with logistic regression.