Trial Outcomes & Findings for MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction (NCT NCT01319760)

Results Overview

Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

3-5 Days post infarct

Results posted on

2019-05-13

Participant Flow

Five roll-in subjects were enrolled in the MINI-AMI feasibility study between September 14, 2011 and April 24, 2012. A total of 82 patients have been screened but not enrolled by participating sites during the study period. Five (5) sites participated in the MINI-AMI study.

The study experienced a very low enrollment rate (lower than expected). The study was terminated before the roll-in phase was completed. No data for primary or secondary endpoints were collected in this study

Participant milestones

Participant milestones
Measure	Control (Standard of Care PCI Without Using Impella) Patients in the control arm will be treated with standard of care for postPCI STEMI patients in accordance with the 2004 ACC/AHA Guidelines for the Management of Patients with STelevation Myocardia Infarction	Experimental (PCI Preceded With Impella 2.5) Patients in this arm will be treated in accordance with standard of care, and in addition will receive 24 hours of support with the Impella 2.5 postPCI for acute myocardial infarction. Impella 2.5 support: Patients enrolled in the Impella arm will receive 24 hours of postPCI hemodynamic support using the Impella 2.5.
Overall Study STARTED	0	5
Overall Study COMPLETED	0	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Patients in the control arm will be treated with standard of care for post-PCI STEMI patients in accordance with the the 2004 ACC/AHA Guidelines for the Management of Patients with ST-elevation Myocardial Infarction. Control: Standard care for STEMI patients post-PCI from ACC/AHA Guidelines	Impella 2.5 n=5 Participants Patients in this arm will be treated in accordance with standard of care, and in addition will receive 24 hours of support with the Impella 2.5 post-PCI for acute myocardial infarction. Impella 2.5 support: Patients enrolled in the Impella arm will receive 24 hours of post-PCI hemodynamic support using the Impella 2.5	Total n=5 Participants Total of all reporting groups
Age, Continuous	—	61.8 years STANDARD_DEVIATION 10.9 • n=4 Participants	61.8 years STANDARD_DEVIATION 10.9 • n=27 Participants
Sex: Female, Male Female	—	2 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	—	3 Participants n=4 Participants	3 Participants n=27 Participants

PRIMARY outcome

Timeframe: 3-5 Days post infarct

Population: No data for primary or secondary endpoints were collected in this study

Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: No data for primary or secondary enpoints were collected

Population: No data from primary or secondary endpoints were collected in this study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 90 Days

Population: No data for primary or secondary endpoints were collected in this study

Assessment of infarct size and remodeling characteristics at 90 days post-infarct.

Outcome measures

Outcome data not reported

Adverse Events

Roll In

Serious events: 3 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Roll In n=5 participants at risk Study close in roll in phase. Therefore, no comparison data available.
Blood and lymphatic system disorders Decrease in Hemolobin	40.0% 2/5 • Number of events 2 • 90 days Study close in roll in phase. Therefore, no comparison data available.
Cardiac disorders Cardiac Arrest	20.0% 1/5 • Number of events 1 • 90 days Study close in roll in phase. Therefore, no comparison data available.
Vascular disorders Cardiogenic Shock	20.0% 1/5 • Number of events 1 • 90 days Study close in roll in phase. Therefore, no comparison data available.
Cardiac disorders chest pain	20.0% 1/5 • Number of events 1 • 90 days Study close in roll in phase. Therefore, no comparison data available.
Renal and urinary disorders Acute renal dysfunction	20.0% 1/5 • Number of events 1 • 90 days Study close in roll in phase. Therefore, no comparison data available.

Other adverse events

Other adverse events
Measure	Roll In n=5 participants at risk Study close in roll in phase. Therefore, no comparison data available.
Blood and lymphatic system disorders Bleeding	20.0% 1/5 • Number of events 1 • 90 days Study close in roll in phase. Therefore, no comparison data available.
Blood and lymphatic system disorders Hematuria	20.0% 1/5 • Number of events 1 • 90 days Study close in roll in phase. Therefore, no comparison data available.
Blood and lymphatic system disorders Hemolysis	40.0% 2/5 • Number of events 2 • 90 days Study close in roll in phase. Therefore, no comparison data available.
Blood and lymphatic system disorders Significant platelet dysfunction	20.0% 1/5 • Number of events 1 • 90 days Study close in roll in phase. Therefore, no comparison data available.
Cardiac disorders Chest pain	40.0% 2/5 • Number of events 2 • 90 days Study close in roll in phase. Therefore, no comparison data available.
Cardiac disorders Worsening heart failure	20.0% 1/5 • Number of events 1 • 90 days Study close in roll in phase. Therefore, no comparison data available.
Renal and urinary disorders Acute Renal Dysfunction	20.0% 1/5 • Number of events 1 • 90 days Study close in roll in phase. Therefore, no comparison data available.
Vascular disorders Hypotension	40.0% 2/5 • Number of events 2 • 90 days Study close in roll in phase. Therefore, no comparison data available.

Additional Information

Dr. Ajay Kirtane

Columbia Presbytarian Hospital, NY

Phone: 212-305-7060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place