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NCT06964685 · ClinicalTrials.gov registry record
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
A clinical trial of AMI Cardiogenic Shock, sponsored by Abiomed.
- Recruiting
- Registry status
- 350
- Enrollment target
- 10
- Study locations
NCT06964685 is a study of AMI Cardiogenic Shock that is actively recruiting participants, run by Abiomed. The registered enrollment target is 350 participants. The trial reports 10 study locations across 10 states.
The verdict
NCT06964685, a study of AMI Cardiogenic Shock, is actively recruiting participants, sponsored by Abiomed.
- RECRUITING
- Registry status
- 350 participants
- Enrollment target
- 10
- Study locations
Study Summary
The observational study titled "Observational Assessment of Support with Impella Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)" aims to evaluate the safety outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) who receive Impella CP during percutaneous coronary intervention (PCI) and who are managed with Impella best practices while receiving guideline-directed standard of care. This prospective, multicenter study will enroll up to 350 hemodynamically unstable patients with cardiogenic shock of less than 12 hours duration and acute myocardial infarction (AMI) of less than 24 hours duration. Cardiogenic shock will be confirmed by tissue hypoperfusion (lactate ≥ 2.5mmol/L and/or SvO2 \<55% with a normal PaO2) and systolic blood pressure \<100 mmHg and/or need for vasopressor therapy (dopamine/norepinepherine or epinephrine). Patients will be assessed for various safety endpoints, including a composite safety endpoint involving major bleeding, acute limb ischemia, and acute kidney injury. Secondary endpoints will evaluate all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), and hospitalizations through 1-year post-Impella implant. All patients presenting with AMICS at study sites will be screened for inclusion in the study after hospital discharge (or after death, if prior to hospital discharge). IRB approved consent waiver will be used to collect data from electronic health records from; Impella placement to discharge and post-discharge at 30 days post-Impella implant, 6 months post-Impella implant, and 1 year post-Impella implant.
Conditions Studied
Interventions
- DEVICE Impella
Study Locations (10)
Arkansas
- Cardiology Associates Research Group (St. Bernard's Hospital) - Jonesboro
California
- St. Joseph Hospital Orange - Orange
Florida
- NCH Rooney Heart Institute - Naples
Michigan
- Henry Ford Health System - Detroit
New Mexico
- New Mexico Heart - Albuquerque
Ohio
- Bethesda North Hospital - Cincinnati
Oklahoma
- St. Francis - Tulsa
Oregon
- Providence St. Vincent Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2025-07-10 |
| Est. Completion | 2028-10-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06964685
The ClinicalTrials.gov registry entry for NCT06964685 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abiomed, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with AMI Cardiogenic Shock appearing as the primary indexed condition, and to 1 intervention - of which Impella is the first listed.
NCT06964685 reports 10 study locations spanning 10 distinct geographic areas - top geographies include Arkansas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06964685 about?
NCT06964685 is a clinical study titled "Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock". The observational study titled "Observational Assessment of Support with Impella Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)" aims to evaluate the safety outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) wh...
What is the current status of trial NCT06964685?
This trial is currently recruiting. The enrollment target is 350 participants. The study started on 2025-07-10. Estimated completion is 2028-10-30.
What conditions does trial NCT06964685 study?
This clinical trial studies the following conditions: AMI Cardiogenic Shock.
What interventions are being tested in trial NCT06964685?
The interventions under investigation include: Impella (DEVICE).
Who is sponsoring clinical trial NCT06964685?
This trial is sponsored by Abiomed, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06964685 being conducted?
This trial has 10 study locations across Arkansas, California, Florida, Michigan, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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