Efficacy of CONservative versus invasive therapy in acute Coronary syndrome with plaque Erosion PhenoType - the CONCEPT-ACS trial - CONCEPT-ACS

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 400 人开始时间: 2023年2月6日最近更新: 2023年9月11日

适应症

试验速览

暂无简介。

•Age >= 18 years;
•Admission with acute coronary syndrome (unstable angina, NSTEMI and STEMI);
•A residual vessel diameter stenosis of less than 70% and Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 after wiring of the culprit vessel (and thrombus aspiration, if needed);
•A diagnosis of plaque erosion by intracoronary OCT imaging of the culprit vessel, with a residual area stenosis <60% and minimum lumen area >3.5 mm2.
•Signed written informed consent to study participation.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 160
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 240

•Age <18 years old;
•Left ventricular ejection fraction (LVEF) < 30%;
•Hypotension, shock, or need for mechanical circulatory support or intravenous vasopressors;
•Contraindication or known hypersensitivity to any of the study drugs (i.e., aspirin, ticagrelor, heparin, and/or colchicine);
•Unstable ventricular arrhythmias;
•Creatinine clearance < 30 ml/min/1.73 m2 (as calculated by MDRD);
•Severe vessel tortuosity or calcification of the culprit vessel, such that it is unlikely that the OCT catheter can be delivered.
•The culprit lesion is a stent thrombosis;
•Life expectancy < 1 year;
•Known history of systemic inflammatory conditions and/or current use or plans to begin chronic systemic steroid therapy (oral or intravenous) during the study (topical or inhaled steroids are allowed);
•History of cancer or lymphoproliferative disease within the last 3 years.
•Refusal to sign the written informed consent to study participation.

发起方

FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE