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NCT Number: NCT04988672

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Luzerner Heart Centre

Lucerne, 6000, Switzerland

Location status: Recruiting

Location contact

Florim Cuculi, MD

CONTACT

[email protected]

+41412052134

Florim Cuculi, MD

PRINCIPAL_INVESTIGATOR

About this study

  • To assess procedural success and clinical outcomes among persons with AMI, who undergo PCI and/ or CABG for AMI (STEMI or NSTEMI)
  • 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)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Rate of major adverse cardiac and cerebrovascular events (MACCE)

    Time frame: 1, 2, 5 and 10 years

  2. Rate of new AMI

    Time frame: 1, 2, 5 and 10 years

  3. Rate of TIA or stroke

    Time frame: 1, 2, 5 and 10 years

  4. Rate of stent thrombosis

    Time frame: 1, 2, 5 and 10 years

  5. Rate of target vessel revascularization

    Time frame: 1, 2, 5 and 10 years

  6. Rate of target lesion failure

    Time frame: 1, 2, 5 and 10 years

  7. Rate of ischemia-driven revascularization

    Time frame: 1, 2, 5 and 10 years

  8. Rate of unstable angina

    Time frame: 1, 2, 5 and 10 years

  9. Rate of rehospitalization for recurrent angina

    Time frame: 1, 2, 5 and 10 years

  10. Rate of hospitalization for heart failure

    Time frame: 1, 2, 5 and 10 years

  11. 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

  12. Rate of cardiovascular mortality

    Time frame: 1, 2, 5 and 10 years

  13. Rate of all-cause mortality

    Time frame: 1, 2, 5 and 10 years

  14. Rate of bleeding events (access site or non-access site related) according to the BARC classification.

    Time frame: 1, 2, 5 and 10 years

  15. Rate of vascular complications (according to VARC criteria)

    Time frame: 1, 2, 5 and 10 years

  16. Rate of new York Heart Association (NYHA) class

    Time frame: 1, 2, 5 and 10 years

  17. Rate of cardiogenic shock

    Time frame: 1, 2, 5 and 10 years

  18. Rate of acute renal failure

    Time frame: 1, 2, 5 and 10 years

  19. Rate of new atrial fibrillation

    Time frame: 1, 2, 5 and 10 years

  20. Rate of new ventricular arrhythmias

    Time frame: 1, 2, 5 and 10 years

  21. Rate of major adverse limb events (MALE)

    Time frame: 1, 2, 5 and 10 years

  22. Rate of periprocedural complications (e.g. coronary perforations, no- reflow)

    Time frame: 1, 2, 5 and 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Florim Cuculi, M.D.

CONTACT

[email protected]

+41412052134

Matthias Bossard, M.D.

CONTACT

[email protected]

+41412051477

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Registry information

Acronym: OPTIMISER

Important dates

Study start
2021
Primary completion
2026
Study completion
2030
First posted
Aug 3, 2021
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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