OPTIMISER Registry - A Prospective Cohort Study to Describe the OPTIMal Management and Outcomes of PatIents PreSEnting With Acute MyocaRdial Infarction
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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
Outcome Measures
Primary Outcome Measures
- Rate of major adverse cardiac and cerebrovascular events (MACCE) (including new AMI, stroke or cardiovascular death) at 1 year [at 1 year]
Secondary Outcome Measures
- Rate of major adverse cardiac and cerebrovascular events (MACCE) [at 180 days, 1, 2, 5 and 10 years]
- Rate of new AMI [at 180 days, 1, 2, 5 and 10 years]
- Rate of TIA or stroke [at 180 days, 1, 2, 5 and 10 years]
- Rate of stent thrombosis [at 180 days, 1, 2, 5 and 10 years]
- Rate of target vessel revascularization [at 180 days, 1, 2, 5 and 10 years]
- Rate of target lesion failure [at 180 days, 1, 2, 5 and 10 years]
- Rate of ischemia-driven revascularization [at 180 days, 1, 2, 5 and 10 years]
- Rate of unstable angina [at 180 days, 1, 2, 5 and 10 years]
- Rate of rehospitalization for recurrent angina [at 180 days, 1, 2, 5 and 10 years]
- Rate of hospitalization for heart failure [at 180 days, 1, 2, 5 and 10 years]
- Rate of rehospitalisation for heart failure, resuscitated cardiac arrest or implantable cardioverter-defibrillator (ICD) implantation at follow- up. [at 180 days, 1, 2, 5 and 10 years]
- Rate of cardiovascular mortality [at 180 days, 1, 2, 5 and 10 years]
- Rate of all-cause mortality [at 180 days, 1, 2, 5 and 10 years]
- Rate of bleeding events (access site or non-access site related) according to the BARC classification. [at 180 days, 1, 2, 5 and 10 years]
- Rate of vascular complications (according to VARC criteria) [at 180 days, 1, 2, 5 and 10 years]
- Rate of new York Heart Association (NYHA) class [at 180 days, 1, 2, 5 and 10 years]
- Rate of cardiogenic shock [at 180 days, 1, 2, 5 and 10 years]
- Rate of acute renal failure [at 180 days, 1, 2, 5 and 10 years]
- Rate of new atrial fibrillation [at 180 days, 1, 2, 5 and 10 years]
- Rate of new ventricular arrhythmias [at 180 days, 1, 2, 5 and 10 years]
- Rate of major adverse limb events (MALE) [at 180 days, 1, 2, 5 and 10 years]
- Rate of periprocedural complications (e.g. coronary perforations, no- reflow) [at 180 days, 1, 2, 5 and 10 years]
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Luzerner Heart Centre | Lucerne | Switzerland | 6000 |
Sponsors and Collaborators
- Luzerner Kantonsspital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-02559