Observational Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
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 250 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Acute myocardial infarction (AMI) of \<36 hours duration from symptom onset to cath lab arrival, confirmed by:

‣ ECG and/or biomarker evidence of ST-segment elevation myocardial infarction (STEMI) or

⁃ ECG and/or biomarker evidence of non-ST-segment elevation myocardial infarction (NSTEMI) and angiographic evidence of one or more culprit vessels

• Cardiogenic shock that develops under one of the following conditions: prior to primary PCI, with \<24 hours from the onset of shock to cath lab arrival, or within 12 hours after initiating primary PCI. Cardiogenic shock is confirmed by at least two of the following:

‣ Peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5 mmol/l or SvO2 \<55% with a normal PaO2)

⁃ Systolic blood pressure \<100 mmHg or need for vasoactive agents to maintain systolic blood pressure ≥100 mmHg

⁃ Hemodynamic criteria represented by a cardiac index of \<2.2 L/min/m2 or a cardiac power output ≤0.6 W

• Patient received PCI to treat the AMI

• Patient was supported with Impella CP as the initial MCS device for cardiogenic shock

• Age ≥18 years

Locations
United States
California
St. Joseph Hospital Orange
RECRUITING
Orange
Kansas
Ascension via Christi
NOT_YET_RECRUITING
Wichita
New Mexico
New Mexico Heart
RECRUITING
Albuquerque
Contact Information
Primary
Sameera Dasari, PhD
sdasar12@its.jnj.com
978-914-8882
Time Frame
Start Date: 2025-07-10
Estimated Completion Date: 2028-10-30
Participants
Target number of participants: 250
Sponsors
Leads: Abiomed Inc.

This content was sourced from clinicaltrials.gov