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

NCT ID: NCT04988672

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2030-12-31

Brief Summary

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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

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* 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.

Conditions

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Myocardial Infarction Myocardial Ischemia STEMI NSTEMI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luzerner Kantonsspital

OTHER

Sponsor Role lead

Responsible Party

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Matthias Bossard

Co-principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Florim Cuculi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Luzerner Kantonsspital

Locations

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Luzerner Heart Centre

Lucerne, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Florim Cuculi, M.D.

Role: CONTACT

+41412052134

Matthias Bossard, M.D.

Role: CONTACT

+41412051477

Facility Contacts

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Florim Cuculi, MD

Role: primary

+41412052134

References

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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.

Reference Type BACKGROUND
PMID: 36700188 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33768799 (View on PubMed)

Other Identifiers

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2020-02559

Identifier Type: -

Identifier Source: org_study_id

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