OPTIMISER Registry - A Prospective Cohort Study to Describe the OPTIMal Management and Outcomes of PatIents PreSEnting With Acute MyocaRdial Infarction (OPTIMISER)

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Myocardial Ischemia; STEMI; NSTEMI

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.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Florim Cuculi, M.D.; Phone Number: +41412052134; Email: florim.cuculi@luks.ch
• Study Contact Backup: Name: Matthias Bossard, M.D.; Phone Number: +41412051477; Email: matthias.bossard@luks.ch

Study Locations

• Switzerland
  • Lucerne, Switzerland, 6000
    • Recruiting
    • Luzerner Heart Centre
    • Principal Investigator: Florim Cuculi, MD
    • Contact: Florim Cuculi, MD; Phone Number: +41412052134; Email: florim.cuculi@luks.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of major adverse cardiac and cerebrovascular events (MACCE) (including new AMI, stroke or cardiovascular death) at 1 year	at 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of major adverse cardiac and cerebrovascular events (MACCE)	1, 2, 5 and 10 years
Rate of new AMI	1, 2, 5 and 10 years
Rate of TIA or stroke	1, 2, 5 and 10 years
Rate of stent thrombosis	1, 2, 5 and 10 years
Rate of target vessel revascularization	1, 2, 5 and 10 years
Rate of target lesion failure	1, 2, 5 and 10 years
Rate of ischemia-driven revascularization	1, 2, 5 and 10 years
Rate of unstable angina	1, 2, 5 and 10 years
Rate of rehospitalization for recurrent angina	1, 2, 5 and 10 years
Rate of hospitalization for heart failure	1, 2, 5 and 10 years
Rate of rehospitalisation for heart failure, resuscitated cardiac arrest or implantable cardioverter-defibrillator (ICD) implantation at follow- up.	1, 2, 5 and 10 years
Rate of cardiovascular mortality	1, 2, 5 and 10 years
Rate of all-cause mortality	1, 2, 5 and 10 years
Rate of bleeding events (access site or non-access site related) according to the BARC classification.	1, 2, 5 and 10 years
Rate of vascular complications (according to VARC criteria)	1, 2, 5 and 10 years
Rate of new York Heart Association (NYHA) class	1, 2, 5 and 10 years
Rate of cardiogenic shock	1, 2, 5 and 10 years
Rate of acute renal failure	1, 2, 5 and 10 years
Rate of new atrial fibrillation	1, 2, 5 and 10 years
Rate of new ventricular arrhythmias	1, 2, 5 and 10 years
Rate of major adverse limb events (MALE)	1, 2, 5 and 10 years
Rate of periprocedural complications (e.g. coronary perforations, no- reflow)	1, 2, 5 and 10 years

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital
• Investigators: Principal Investigator: Florim Cuculi, M.D., Luzerner Kantonsspital

Publications and helpful links

General 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.cjco.2022.11.002. eCollection 2023 Jan.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: July 25, 2021
• First Submitted That Met QC Criteria: July 25, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: 2020-02559

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No