NCT04988672

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jan 2021Dec 2030

Study Start

First participant enrolled

January 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

6 years

First QC Date

July 25, 2021

Last Update Submit

October 4, 2023

Conditions

Myocardial InfarctionMyocardial IschemiaSTEMINSTEMI

Outcome Measures

Primary Outcomes (1)

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

    at 1 year

Secondary Outcomes (22)

  • 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

  • +17 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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).

You may not qualify if:

  • Patient unwilling or unable to provide informed consent
  • Patients with no ACS/AMI (e.g. Takotsubo cardiomyopathy, acute heart failure not related to AMI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luzerner Heart Centre

Lucerne, 6000, Switzerland

RECRUITING

Related Publications (2)

  • 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.

    PMID: 36700188BACKGROUND

  • 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: 33768799BACKGROUND

MeSH Terms

Conditions

Myocardial InfarctionMyocardial IschemiaST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Florim Cuculi, M.D.

    Luzerner Kantonsspital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florim Cuculi, M.D.

CONTACT

+41412052134florim.cuculi@luks.ch

Matthias Bossard, M.D.

CONTACT

+41412051477matthias.bossard@luks.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-principal Investigator

Study Record Dates

First Submitted

July 25, 2021

First Posted

August 3, 2021

Study Start

January 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2030

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

CH(1)