Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Public ClinicalTrials.gov record NCT06964685. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Observational Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06964685
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 350 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 9, 2025
- Primary completion
- Sep 29, 2027
- Completion
- Oct 29, 2028
- Last update posted
- Jul 5, 2026
2025 – 2028
United States locations
- U.S. sites
- 18
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiology Associates Research Group (St. Bernard's Hospital) | Jonesboro | Arkansas | 72401 | Recruiting |
| St. Joseph Hospital Orange | Orange | California | 92868 | Recruiting |
| Torrance Memorial Medical Center | Torrance | California | 90505 | Recruiting |
| NCH Rooney Heart Institute | Naples | Florida | 34102 | Recruiting |
| Straub Benioff Medical Center | Honolulu | Hawaii | 96813 | Recruiting |
| OSF Saint Francis | Peoria | Illinois | 61637 | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Recruiting |
| Henry Ford Health System | Detroit | Michigan | 48202 | Recruiting |
| New Mexico Heart | Albuquerque | New Mexico | 87102 | Recruiting |
| Bethesda North Hospital | Cincinnati | Ohio | 45242 | Recruiting |
| Saint Francis Hospital | Tulsa | Oklahoma | 74136 | Recruiting |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | Recruiting |
| Legacy Emanuel Medical Center | Portland | Oregon | 97227 | Recruiting |
| Parkwest Medical Center | Knoxville | Tennessee | 37923 | Recruiting |
| Texas Health Presbyterian Hospital Dallas | Dallas | Texas | 75231 | Recruiting |
| UTHealth Memorial Hermann | Houston | Texas | 77030 | Recruiting |
| Methodist Hospital | San Antonio | Texas | 78229 | Recruiting |
| Inova Fairfax | Falls Church | Virginia | 22042 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06964685, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 5, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06964685 live on ClinicalTrials.gov.