Clinical trial NCT04988672: OPTIMISER Registry - A Prospective Cohort Study to Describe the OPTIMal Management and Outcomes of PatIents PreSEnting With Acute MyocaRdial Infarction
Official title: OPTIMISER Registry - A Prospective Cohort Study to Describe the OPTIMal Management and Outcomes of PatIents PreSEnting With Acute MyocaRdial Infarction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Myocardial Ischemia
STEMI
NSTEMI
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In an all-comers design, virtually any AMI patient treated with PCI or CABG at the Cardiology Division of Lucerne Cantonal Hospital and giving consent may be included. We expect a total inclusion rate of around 400 patients per year at the LUKS. The prospective recruitment is planned to continue for 10 years, which results in 4000 patients in the prospective arm. In addition, a retrospective arm will include a random sample of 500 patients who presented with AMI and were treated with PCI or CABG in the 5 years prior to study start (2016-2020).

Brief summary: 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.

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)

Primary outcomes:
measure: Rate of major adverse cardiac and cerebrovascular events (MACCE) (including new AMI, stroke or cardiovascular death) at 1 year
timeFrame: at 1 year
Secondary outcomes:
measure: Rate of major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: 1, 2, 5 and 10 years
measure: Rate of new AMI
timeFrame: 1, 2, 5 and 10 years
measure: Rate of TIA or stroke
timeFrame: 1, 2, 5 and 10 years
measure: Rate of stent thrombosis
timeFrame: 1, 2, 5 and 10 years
measure: Rate of target vessel revascularization
timeFrame: 1, 2, 5 and 10 years
measure: Rate of target lesion failure
timeFrame: 1, 2, 5 and 10 years
measure: Rate of ischemia-driven revascularization
timeFrame: 1, 2, 5 and 10 years
measure: Rate of unstable angina
timeFrame: 1, 2, 5 and 10 years
measure: Rate of rehospitalization for recurrent angina
timeFrame: 1, 2, 5 and 10 years
measure: Rate of hospitalization for heart failure
timeFrame: 1, 2, 5 and 10 years
measure: Rate of rehospitalisation for heart failure, resuscitated cardiac arrest or implantable cardioverter-defibrillator (ICD) implantation at follow- up.
timeFrame: 1, 2, 5 and 10 years
measure: Rate of cardiovascular mortality
timeFrame: 1, 2, 5 and 10 years
measure: Rate of all-cause mortality
timeFrame: 1, 2, 5 and 10 years
measure: Rate of bleeding events (access site or non-access site related) according to the BARC classification.
timeFrame: 1, 2, 5 and 10 years
measure: Rate of vascular complications (according to VARC criteria)
timeFrame: 1, 2, 5 and 10 years
measure: Rate of new York Heart Association (NYHA) class
timeFrame: 1, 2, 5 and 10 years
measure: Rate of cardiogenic shock
timeFrame: 1, 2, 5 and 10 years
measure: Rate of acute renal failure
timeFrame: 1, 2, 5 and 10 years
measure: Rate of new atrial fibrillation
timeFrame: 1, 2, 5 and 10 years
measure: Rate of new ventricular arrhythmias
timeFrame: 1, 2, 5 and 10 years
measure: Rate of major adverse limb events (MALE)
timeFrame: 1, 2, 5 and 10 years
measure: Rate of periprocedural complications (e.g. coronary perforations, no- reflow)
timeFrame: 1, 2, 5 and 10 years
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Luzerner Heart Centre
Study officials:
affiliation: Luzerner Kantonsspital
name: Florim Cuculi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.cjco.2022.11.002. eCollection 2023 Jan.
citation: 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.