OPTIMISER Registry - A Prospective Cohort Study to Describe the OPTIMal Management and Outcomes of PatIents PreSEnting With Acute MyocaRdial Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Myocardial Infarction, Myocardial Ischemia, STEMI, NSTEMI. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The purpose of the OPTIMISER Registry is to prospectively and retrospectively collect baseline, clinical and procedural data in patients who present with AMI and are treated with PCI as well as prospectively collect the clinical outcome data. Outcomes will be compared in different clinical subgroups. The impact of PCI in AMI in general as well as cardiovascular outcomes after AMI will be assessed.
Detailed description
* To assess procedural success and clinical outcomes among persons with AMI, who undergo PCI and/ or CABG for AMI (STEMI or NSTEMI)
1. Periprocedural outcomes/ complications, which will be analyzed, represent: final result (e.g. TIMI flow), stent expansion, dissections, perforations, prevalence of thrombus (assessed by angiography and intravascular imaging) 2. Short and long-term clinical outcomes of interest including: new AMI, unstable angina (UA), stent-/scaffold thrombosis, target lesion failure, target vessel revascularization, ischemia driven revascularization, repeat hospitalization, new/worsening heart failure, cardiogenic shock, stroke, bleedings, cardiovascular death and all-cause death. * To describe procedural and clinical performance of various balloon, stent and scaffold devices implanted in patients presenting with AMI during the afore mentioned period * To study the impact of different devices and strategies used for lesion preparation and PCI optimization strategies among patients undergoing PCI * To describe early and late angiographic and OCT-findings among coronary artery disease in patients with AMI treated with various metallic stent and scaffold devices * To assess possible predictors for coronary stent implantation or device failure * To evaluate the impact of different antithrombotic regimens on patient clinical outcomes * To study procedural and clinical outcomes among CAD patients requiring hemodynamic support using mechanical devices. * To describe economic implications (cost-effectiveness) of various interventional treatments for CAD.
Primary outcome measures
- Rate of major adverse cardiac and cerebrovascular events (MACCE) (including new AMI, stroke or cardiovascular death) at 1 year [Time frame: at 1 year]
Secondary outcome measures (12)
- Rate of major adverse cardiac and cerebrovascular events (MACCE) [Time frame: 1, 2, 5 and 10 years]
- Rate of new AMI [Time frame: 1, 2, 5 and 10 years]
- Rate of TIA or stroke [Time frame: 1, 2, 5 and 10 years]
- Rate of stent thrombosis [Time frame: 1, 2, 5 and 10 years]
- Rate of target vessel revascularization [Time frame: 1, 2, 5 and 10 years]
- Rate of target lesion failure [Time frame: 1, 2, 5 and 10 years]
- Rate of ischemia-driven revascularization [Time frame: 1, 2, 5 and 10 years]
- Rate of unstable angina [Time frame: 1, 2, 5 and 10 years]
- Rate of rehospitalization for recurrent angina [Time frame: 1, 2, 5 and 10 years]
- Rate of hospitalization for heart failure [Time frame: 1, 2, 5 and 10 years]
- Rate of rehospitalisation for heart failure, resuscitated cardiac arrest or implantable cardioverter-defibrillator (ICD) implantation at follow- up. [Time frame: 1, 2, 5 and 10 years]
- Rate of cardiovascular mortality [Time frame: 1, 2, 5 and 10 years]
Eligibility criteria
Inclusion criteria
- Subject >18 years of age
- Individuals who are newly diagnosed with AMI or have been diagnosed with AMI (STEMI or NSTEMI) within the last 5 years (since 2016).
- Subjects must be willing to sign a patient informed consent (PIC) OR a patient ́s relative/ proxy are willing to provide PIC or patients have signed the General Consent (GK).
Exclusion criteria
- Patient unwilling or unable to provide informed consent
- Patients with no ACS/AMI (e.g. Takotsubo cardiomyopathy, acute heart failure not related to AMI)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Luzerner Heart Centre — Lucerne
Publications
- Tersalvi G, Attinger-Toller A, Kalathil D, Winterton D, Cioffi GM, Madanchi M, Seiler T, Stadelmann M, Goffredo F, Fankhauser P, Moccetti F, Wolfrum M, Toggweiler S, Bloch A, Kobza R, Cuculi F, Bossard M. Trajectories of Cardiac Function Following Treatment With an Impella Device in Patients With Acute Anterior ST-Elevation Myocardial Infarction. CJC Open. 2022 Nov 5;5(1):77-85. doi: 10.1016/j.cjc PMID 36700188
- Cioffi GM, Madanchi M, Bossard M, Cuculi F. Deferring stent optimization in stent thrombosis: A novel approach for STEMI management-Insights from a case series. Clin Case Rep. 2021 Feb 13;9(3):1150-1154. doi: 10.1002/ccr3.3697. eCollection 2021 Mar. PMID 33768799
Identifiers
NCT: NCT04988672 · 2020-02559