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

Myocardial Infarction Clinical Trial

— OPTIMISER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04988672
• Other study ID #: 2020-02559
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2030

Study information

• Verified date: October 2023
• Source: Luzerner Kantonsspital
• Contact: Florim Cuculi, M.D.
• Phone: +41412052134
• Email: florim.cuculi[@]luks.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia
• NSTEMI
• STEMI

Locations

Country	Name	City	State
Switzerland	Luzerner Heart Centre	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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