Myocardial InfarctionOPTIMISERNCT04988672
OPTIMISER Registry - A Prospective Cohort Study to Describe the OPTIMal Management and Outcomes of PatIents PreSEnting With Acute MyocaRdial Infarction
An observational study of Myocardial Infarction and Myocardial Ischemia, run by Luzerner Kantonsspital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Myocardial Ischemia, STEMI
- How many people
- 4,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2021to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- Patient unwilling or unable to provide informed consent
- Patients with no ACS/AMI (e.g. Takotsubo cardiomyopathy, acute heart failure not related to AMI)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Luzerner Heart Centre
Lucerne, 6000
Florim Cuculi, MD, +41412052134, florim.cuculi@luks.ch
Florim Cuculi, MD
About this study
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.
Read the detailed description
- 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.
- Conditions
- Myocardial Infarction, Myocardial Ischemia, STEMI, NSTEMI
- Medical subject headings
- Myocardial Infarction, Myocardial Ischemia, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major adverse cardiac and cerebrovascular events (MACCE) (including new AMI, stroke or cardiovascular death) at 1 year
Measured: at 1 year
Secondary outcomes (22)
Rate of major adverse cardiac and cerebrovascular events (MACCE)
Measured: 1, 2, 5 and 10 years
Rate of new AMI
Measured: 1, 2, 5 and 10 years
Rate of TIA or stroke
Measured: 1, 2, 5 and 10 years
Rate of stent thrombosis
Measured: 1, 2, 5 and 10 years
Rate of target vessel revascularization
Measured: 1, 2, 5 and 10 years
Rate of target lesion failure
Measured: 1, 2, 5 and 10 years
Rate of ischemia-driven revascularization
Measured: 1, 2, 5 and 10 years
Rate of unstable angina
Measured: 1, 2, 5 and 10 years
Rate of rehospitalization for recurrent angina
Measured: 1, 2, 5 and 10 years
Rate of hospitalization for heart failure
Measured: 1, 2, 5 and 10 years
Rate of rehospitalisation for heart failure, resuscitated cardiac arrest or implantable cardioverter-defibrillator (ICD) implantation at follow- up.
Measured: 1, 2, 5 and 10 years
Rate of cardiovascular mortality
Measured: 1, 2, 5 and 10 years
Rate of all-cause mortality
Measured: 1, 2, 5 and 10 years
Rate of bleeding events (access site or non-access site related) according to the BARC classification.
Measured: 1, 2, 5 and 10 years
Rate of vascular complications (according to VARC criteria)
Measured: 1, 2, 5 and 10 years
Rate of new York Heart Association (NYHA) class
Measured: 1, 2, 5 and 10 years
Rate of cardiogenic shock
Measured: 1, 2, 5 and 10 years
Rate of acute renal failure
Measured: 1, 2, 5 and 10 years
Rate of new atrial fibrillation
Measured: 1, 2, 5 and 10 years
Rate of new ventricular arrhythmias
Measured: 1, 2, 5 and 10 years
Rate of major adverse limb events (MALE)
Measured: 1, 2, 5 and 10 years
Rate of periprocedural complications (e.g. coronary perforations, no- reflow)
Measured: 1, 2, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Bossard, Luzerner Kantonsspital
- Investigators
- Florim Cuculi, M.D., Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988672
- Sponsor's protocol ID
- 2020-02559
- Acronym
- OPTIMISER
- Status last verified
- Oct 2023
- First submitted
- 25 Jul 2021
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36700188Cioffi 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.
PubMed 33768799
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMISER Registry - A Prospective Cohort Study to Describe the OPTIMal Management and Outcomes of PatIents PreSEnting With Acute MyocaRdial Infarction
- ClinicalTrials.gov ID
- NCT04988672
- Acronym / sponsor ID
- OPTIMISER / 2020-02559
- Conditions
- Myocardial Infarction, Myocardial Ischemia, STEMI, NSTEMI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Patient unwilling or unable to provide informed consent
- Patients with no ACS/AMI (e.g. Takotsubo cardiomyopathy, acute heart failure not related to AMI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of major adverse cardiac and cerebrovascular events (MACCE) (including new AMI, stroke or cardiovascular death) at 1 year
Time frame: at 1 year
22 secondary outcomes
Rate of major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 1, 2, 5 and 10 years
Rate of new AMI
Time frame: 1, 2, 5 and 10 years
Rate of TIA or stroke
Time frame: 1, 2, 5 and 10 years
Rate of stent thrombosis
Time frame: 1, 2, 5 and 10 years
Rate of target vessel revascularization
Time frame: 1, 2, 5 and 10 years
Rate of target lesion failure
Time frame: 1, 2, 5 and 10 years
Rate of ischemia-driven revascularization
Time frame: 1, 2, 5 and 10 years
Rate of unstable angina
Time frame: 1, 2, 5 and 10 years
Rate of rehospitalization for recurrent angina
Time frame: 1, 2, 5 and 10 years
Rate of hospitalization for heart failure
Time frame: 1, 2, 5 and 10 years
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
Rate of cardiovascular mortality
Time frame: 1, 2, 5 and 10 years
Rate of all-cause mortality
Time frame: 1, 2, 5 and 10 years
Rate of bleeding events (access site or non-access site related) according to the BARC classification.
Time frame: 1, 2, 5 and 10 years
Rate of vascular complications (according to VARC criteria)
Time frame: 1, 2, 5 and 10 years
Rate of new York Heart Association (NYHA) class
Time frame: 1, 2, 5 and 10 years
Rate of cardiogenic shock
Time frame: 1, 2, 5 and 10 years
Rate of acute renal failure
Time frame: 1, 2, 5 and 10 years
Rate of new atrial fibrillation
Time frame: 1, 2, 5 and 10 years
Rate of new ventricular arrhythmias
Time frame: 1, 2, 5 and 10 years
Rate of major adverse limb events (MALE)
Time frame: 1, 2, 5 and 10 years
Rate of periprocedural complications (e.g. coronary perforations, no- reflow)
Time frame: 1, 2, 5 and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 36700188Tersalvi 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.
- Background: PubMed 33768799Cioffi 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.
Related trials for Myocardial Infarction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florim Cuculi, M.D. principal investigator
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Myocardial Ischemia, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florim Cuculi, M.D. (+41412052134, florim.cuculi@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major adverse cardiac and cerebrovascular events (MACCE) (including new AMI, stroke or cardiovascular death) at 1 year (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988672, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.