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70 active trials for Percutaneous Coronary Intervention

Comparison Between Fasting and no Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events

Traditionally, patients are asked to fast prior to invasive cardiac procedures. There exists neither clear evidence nor guidance about the benefits of this. Hypothesis/Objective : To show that allowing unrestricted oral intake before a coronary interventional procedure is not inferior to imposing a pre-procedural fasting period, in terms of adverse events, in patients requiring coronary angiography or a planned or semi-urgent percutaneous coronary intervention. Method: The study is a prospective, monocentric, controlled, single-blind, randomized trial in two parallel arms. The investigating physician performing the interventional procedure and evaluating the safety judgment criteria will not be informed of the patient's randomization arm. In order to keep the blind, the medical and paramedical staff of the interventional cardiology room will not inquire about the fasting status of patients included in the study. Patients are randomized either to the pre-procedural fasting arm or to the absence of pre-procedural fasting. No intervention: Pre-procedural fasting is defined by the absence of ingestion of fluids or solid food for at least 6 hours before the examination. Experimental: free feeding and drinking until the procedure. Patients are followed for 4 hours after the end of the procedure at the hospital for adverse events (vagal discomfort, nausea, vomiting or hypoglycaemia). Then a follow-up will be done at day 7 after the procedure (by telephone for outpatients or discharged from the hospital and in the cardiology department for patients still hospitalized on D7) to look for the occurrence of acute renal failure or pneumonia

Start: December 2019
Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction

Study type: prospective cohort and randomized trial. Duration: estimated 2 years. Indications: Type II myocardial infarction in critically ill patients. Purpose: To recognise the incidence of type I myocardial infarction (MI) in patients with suspected type II MI. Determining the safety of early coronary angiography in this population. Assessment of the effect of percutaneous coronary revascularization in critically ill patients with stable obstructive coronary disease and type II MI. Hypotheses: Obstructive coronary artery disease suitable for percutaneous revascularization is present in majority of patients with type II MI. Type I MI (acute coronary artery thrombosis) is present in some patients and not recognised. Echocardiogram and a 12-lead electrocardiogram are not reliable in predicting coronary artery disease. Urgent invasive diagnostic is safe in patients with type II MI. Percutaneous revascularization (if indicated) reduces the size of myocardial necrosis in patients with type II MI. Objectives: Primary endpoint: to demonstrate that percutaneous coronary intervention (PCI) in the group with obstructive coronary disease reduces the size of MI. Secondary endpoints: improved cardiac function after revascularization, shorter hospitalization, reduced mortality. Safety objective: renal function, bleeding complications. Population: 140 patients with type II MI over 18 years of age with no evidence of active bleeding. Inclusion criteria: age> 18 years High sensitive troponin I > 40 ng / L for women and > 58ng / L for men Critical illness (at least one vital organ support) Imaging signs (electrocardiogram or ultrasound) signs of myocardial ischemia Exclusion criteria: active bleeding terminal illness Monitoring of patients: during hospitalization, 30 days after discharge, 6 months after discharge. Performance check: PCI success (% of "thrombolysis in myocardial infarction" flow 3) the size of MI (troponin area under the curve) left ventricular ejection fraction hospital stay 30 day survival Safety Check: monitoring of renal function monitoring of bleeding complications monitoring of allergic reactions to contrast and medication Patient Consent: written informed consent for inclusion in the study in conscious population. In unconscious patients, written consent will be obtained in the event of mental function improvement.

Start: September 2019