Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study (DTU)

May 2, 2019 updated by: Abiomed Inc.

Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study

Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A multi-center, prospective, randomized, two-arm feasibility trial to assess the potential role of unloading with the Impella CP prior to revascularization in reducing infarct size. The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate Arm: initiation of Impella CP unloading followed immediately by PPCI.

Study Hypothesis: Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Good Samaritan Medical Center
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Wellstar/Kennestone Hospital
    • Illinois
      • Detroit, Illinois, United States, 48201
        • Detroit Medical Center
      • Oakbrook Terrace, Illinois, United States, 60089
        • Advocate Edward Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Danvers, Massachusetts, United States, 01923
        • ABIOMED, Inc.
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Medical Center
    • New York
      • Buffalo, New York, United States, 14203
        • University of Buffalo Hospital
      • Manhasset, New York, United States, 11030
        • Northwell Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 48201
        • Greenville Health System
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Age 21-80 years
  • First myocardial infarction
  • Acute anterior STEMI with ≥ 2 mm in 2 or more contiguous anterior leads or≥ 4 mm total ST-segment deviation sum in the anterior leads
  • Signed Informed Consent

Main Exclusion Criteria:

  • Cardiogenic shock defined as: systemic hypotension (systolic BP less than 90 mmHg or the need for inotropes/pressors to maintain a systolic BP Greater than 90mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the cath lab, clinical evidence of end organ hypoperfusion, lactate level greater than 2.5mmol/L
  • Inferior STEMI or suspected right ventricular failure
  • Suspected or known pregnancy
  • Suspected active infection
  • History or known hepatic insufficiency prior to catheterization
  • On dialysis therapy
  • Known contraindication to:
  • Undergoing MRI or use of gadolinium
  • Heparin, pork, pork products or contrast media
  • Receiving a drug-eluting stent
  • Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Prolonged unloading prior to PPCI
Activation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention
Device: Impella unloading prior to PPCI
Impella unloading prior to PPCI
ACTIVE_COMPARATOR: Immediate unloading prior to PPCI
Activation of Impella CP immediately prior to primary percutaneous coronary intervention
Device: Impella unloading prior to PPCI
Impella unloading prior to PPCI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Infarct size at 30 Days
Time Frame: 30 Days
Assessment of infarct size as percent of left ventricular (LV) mass, evaluated using CMR, at 30 days post-PPCI
30 Days
MACCE at 30 Days
Time Frame: 30 Days

A composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days:

  • Cardiovascular mortality
  • Re-infarction
  • Stroke/TIA
  • Major vascular complication
30 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infarct Characteristics - LV mass
Time Frame: 3 - 5 and 30 Days
Using CMR at 3-5 & 30 days, assessement of Infarct size as a percent of LV mass
3 - 5 and 30 Days
Infarct Characteristics - area at risk
Time Frame: 3 - 5 and 30 Days
Using CMR at 3-5 & 30 days, assessment of Infarct size as a percent of area (myocardium) at risk,
3 - 5 and 30 Days
30 Day Safety Endpoint Rates
Time Frame: 30 Days
Event rate for All-cause mortality, Cardiovascular mortality, Re-infarction, Stroke/TIA, Vascular complications, Worsening heart failure or hemodynamic compromise requiring inotropic or hemodynamic support post Impella explant, Repeat revascularization, Aortic valve injury or dysfunction, Renal failure, Hemolysis, Hematoma, Bleeding, Thrombocytopenia
30 Days
Infarct Characteristics microvascular obstruction
Time Frame: 3-5 and 30 Days
Using CMR at 3-5 & 30 days, measurement of percent of microvascular obstruction (%MVO)
3-5 and 30 Days
Left Ventricular Function- LV end systolic and diastolic volume index
Time Frame: 3-5 and 30 Days
Using CMR imaging post PCI: assessment of LV end systolic and diastolic volume index (LVESVi & LVEDVi)
3-5 and 30 Days
Left Ventricular Function - Ejection Fraction
Time Frame: 3-5 and 30 Days
Using CMR at 3-5 & 30 days post PCI: assessment of Ejection fraction (EF)
3-5 and 30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abiomed Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DTU - Safety and Feasibility

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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