Cangrelor in Patients With Acute Myocardial Infarction Undergoing PCI After CPR, Ventilated or Cardiogenic Shock
- Conditions
- Acute Myocardial Infarction
- Registration Number
- NCT04611607
- Lead Sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Brief Summary
This registry will provide information about the efficacy and safety of cangrelor in a very high-risk group of patients with acute myocardial infarction undergoing PCI. It will not only include patients with cardiogenic shock, but a variety of patients not able to swallow tablets, such as those after CPR and/or with invasive or non-invasive ventilation. Therefore it will provide information about the use of cangrelor beyond the current knowledge.
- Detailed Description
This registry is a non-interventional, multicentre, retrospective cohort study in patients with acute myocardial infarction undergoing PCI after CRP, ventilated and/or with cardiogenic shock.
The study is purely observational; data will be documented retrospectively based on available medical records. No additional data will be collected, no study-related treatment will be initiated.
About 10 - 20 high-volume PCI clinics in Germany treating patients with myocardial infarction are eligible for participation. Participating sites will be given a maximum of 6 months for retrospectively documenting eligible patients.
Eligible are all patients with acute myocardial infarction (STEMI, NSTEMI) who underwent PCI after CRP, ventilated and/or with cardiogenic shock and were treated with cangrelor during index procedure. It is planned to enrol about 400 patients in total. Patient characteristics, procedural details and clinical events occurring during the period between index MI and discharge or death (whichever came first) will be documented based on the relevant existing medical charts of the patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 303
- Age ≥18 years
- Acute Myocardial infarction (NSTEMI or STEMI)
- PCI with stent implantation
- Treatment with cangrelor during index procedure
- At least one of the following criteria:
- CPR prior to PCI
- Cardiogenic shock
- Heart failure with the need for mechanical or non-invasive ventila-tion
No explicit medical exclusion criteria are stated to avoid selection bias.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Definite stent thrombosis from procedure for index MI up to 48 hours Rate of stent thromboses
Recurrent myocardial infarction from procedure for index MI up to 48 hours Rate of recurrent myocardial infarction according to the universal definition of MI
- Secondary Outcome Measures
Name Time Method Recurrent myocardial infarction from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days Rate of recurrent myocardial infarction according to the universal definition of MI
Mortality from procedure for index MI until discharge from hospital; up to 30 days Rate of death
Definite stent thrombosis from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days Rate of stent thromboses
Bleeding complications from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days Rate of bleeding complication according to BARC definition
Trial Locations
- Locations (10)
Universitätsklinikum Graz
🇦🇹Graz, Austria
Fürst-Stirum Klinikum Bruchsal
🇩🇪Bruchsal, Germany
Klinik Ottakring
🇦🇹Wien, Austria
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Klinikum Leverkusen
🇩🇪Leverkusen, Germany
Klinikum Ludwigshafen
🇩🇪Ludwigshafen, Germany
Hegau-Bodensee Klinikum Singen
🇩🇪Singen, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Krankenhaus Maria-Hilf
🇩🇪Stadtlohn, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany