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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.
To assess procedural success and clinical outcomes among persons with AMI, who undergo PCI and/ or CABG for AMI (STEMI or NSTEMI)
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of major adverse cardiac and cerebrovascular events (MACCE) (including new AMI, stroke or cardiovascular death) at 1 year | at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florim Cuculi, M.D. | Contact | +41412052134 | florim.cuculi@luks.ch | |
| Matthias Bossard, M.D. | Contact | +41412051477 | matthias.bossard@luks.ch |
| Name | Affiliation | Role |
|---|---|---|
| Florim Cuculi, M.D. | Luzerner Kantonsspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luzerner Heart Centre | Recruiting | Lucerne | 6000 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36700188 | Background | 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. | |
| 33768799 |
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| 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 |
| Rate of target lesion failure | 1, 2, 5 and 10 years |
| Rate of ischemia-driven revascularization | 1, 2, 5 and 10 years |
| Rate of unstable angina | 1, 2, 5 and 10 years |
| Rate of rehospitalization for recurrent angina | 1, 2, 5 and 10 years |
| Rate of hospitalization for heart failure | 1, 2, 5 and 10 years |
| Rate of rehospitalisation for heart failure, resuscitated cardiac arrest or implantable cardioverter-defibrillator (ICD) implantation at follow- up. | 1, 2, 5 and 10 years |
| Rate of cardiovascular mortality | 1, 2, 5 and 10 years |
| Rate of all-cause mortality | 1, 2, 5 and 10 years |
| Rate of bleeding events (access site or non-access site related) according to the BARC classification. | 1, 2, 5 and 10 years |
| Rate of vascular complications (according to VARC criteria) | 1, 2, 5 and 10 years |
| Rate of new York Heart Association (NYHA) class | 1, 2, 5 and 10 years |
| Rate of cardiogenic shock | 1, 2, 5 and 10 years |
| Rate of acute renal failure | 1, 2, 5 and 10 years |
| Rate of new atrial fibrillation | 1, 2, 5 and 10 years |
| Rate of new ventricular arrhythmias | 1, 2, 5 and 10 years |
| Rate of major adverse limb events (MALE) | 1, 2, 5 and 10 years |
| Rate of periprocedural complications (e.g. coronary perforations, no- reflow) | 1, 2, 5 and 10 years |
| Background |
| 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. |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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