All > Myocardial Infarction > Virginia

Impella CP® placement prior to reperfusion with Primary PCI for Myocardial Infarction

Carilion Clinic, Roanoke, VA
Myocardial InfarctionImpella CP® placement prior to reperfusion with Primary PCI - Device
Eligibility
18 - 85
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether using a temporary circulatory assist device for 30 minutes prior to a catheterization procedure can reduce heart damage from a heart attack.

Eligible Conditions
  • ST Elevation Myocardial Infarction (STEMI)

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Similar Trials

1
CardiolRx
1
Hemorrhagic Myocardial Infarction - Deferiprone
1
PEP in Acute Myocardial Infarction

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 12 Months

12 Months
Cardiogenic Shock, CV mortality, Heart Failure, LVAD or Heart Transplant and ICD or CRT Placement
3-5 days
Infarct Size, as a percent of Left Ventricular Mass
3-5 days post-procedure
Infarct Size
30 Days
Impella CP® related Major Bleeding and Major Vascular complications

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

2
CardiolRx
1
Hemorrhagic Myocardial Infarction - Deferiprone
1
PEP in Acute Myocardial Infarction

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Control
1 of 2
Experimental
1 of 2

Active Control

Experimental Treatment

668 Total Participants · 2 Treatment Groups

Primary Treatment: Impella CP® placement prior to reperfusion with Primary PCI · No Placebo Group · N/A

Experimental
Device
Experimental Group · 1 Intervention: Impella CP® placement prior to reperfusion with Primary PCI · Intervention Types: Device
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Abiomed Inc.Lead Sponsor
40 Previous Clinical Trials
33,445 Total Patients Enrolled
7 Trials studying Myocardial Infarction
1,168 Patients Enrolled for Myocardial Infarction
Navin Kapur, MDPrincipal InvestigatorTufts University Medical Center
2 Previous Clinical Trials
575 Total Patients Enrolled
1 Trials studying Myocardial Infarction
560 Patients Enrolled for Myocardial Infarction
William O'Neill, MDPrincipal InvestigatorHenry Ford Hospital
6 Previous Clinical Trials
12,194 Total Patients Enrolled
1 Trials studying Myocardial Infarction
560 Patients Enrolled for Myocardial Infarction

Eligibility Criteria

Age 18 - 85 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a heart attack before.
References

Frequently Asked Questions

Are patients of all ages eligible for this research?

"The age range for this study is 18 to 80 years old." - Anonymous Online Contributor

Unverified Answer

At how many institutions is this research being conducted?

"Enrollment for this clinical trial is currently taking place at University of Buffalo Hospital, The University of Texas Health Science Center at Houston, Sentara Norfolk General Hospital and an additional 46 medical facilities." - Anonymous Online Contributor

Unverified Answer

How many guinea pigs are a part of this experiment?

"That is correct. The study, which began recruiting on December 12th 2019, is still looking for 668 participants at 46 sites around the world according to the latest update from July 14th 2022." - Anonymous Online Contributor

Unverified Answer

Which patients would be a good match for this clinical trial?

"668 individuals aged 18-80 who have had an infarction are being recruited for this study. In order to participate, patients must meet the following age and presentation criteria: 18-80 years old and hospital arrival 1-5 hours after onset of ischemic pain." - Anonymous Online Contributor

Unverified Answer

Are people with the necessary qualifications currently being sought for this research project?

"That is correct. The clinical trial, which began recruitment on December 12th 2019, is still ongoing according to the information available on clinicaltrials.gov. There are currently 668 participants enrolled at 46 sites around the world." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top