STEMIDTUNCT03000270
Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study
A study testing Impella unloading prior to PPCI in people with STEMI, run by Abiomed Inc. at 15 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- STEMI
- What is being tested?
- Impella unloading prior to PPCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 15 sitesUnited States
- Study dates
- 11 Apr 2017to 16 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Tufts Medical Center
Boston, Massachusetts, 02111
University of Buffalo Hospital
Buffalo, New York, 14203
ABIOMED, Inc.
Danvers, Massachusetts, 01923
Detroit Medical Center
Detroit, Illinois, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Spectrum
Grand Rapids, Michigan, 49503
Greenville Health System
Greenville, South Carolina, 48201
Hackensack Medical Center
Hackensack, New Jersey, 07601
Northwell Health
Manhasset, New York, 11030
Wellstar/Kennestone Hospital
Marietta, Georgia, 30060
West Virginia University Hospital
Morgantown, West Virginia, 26506
Advocate Edward Hospital
Oakbrook Terrace, Illinois, 60089
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: 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
Read the 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
- Conditions
- STEMI
- Being tested
- Impella unloading prior to PPCI
- Keywords
- Infarct Size, Impella, Unloading, Left Ventricle, PPCI, STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella unloading prior to PPCIDevice
Impella unloading prior to PPCI
| Study group | Role | What they receive |
|---|---|---|
| Prolonged unloading prior to PPCI | Active comparator | Activation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention Receives: Device: Impella unloading prior to PPCI |
| Immediate unloading prior to PPCI | Active comparator | Activation of Impella CP immediately prior to primary percutaneous coronary intervention Receives: Device: Impella unloading prior to PPCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size at 30 Days
Assessment of infarct size as percent of left ventricular (LV) mass, evaluated using CMR, at 30 days post-PPCI
Measured: 30 Days
MACCE at 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
Measured: 30 Days
Secondary outcomes (6)
Infarct Characteristics - LV mass
Using CMR at 3-5 \& 30 days, assessement of Infarct size as a percent of LV mass
Measured: 3 - 5 and 30 Days
Infarct Characteristics - area at risk
Using CMR at 3-5 \& 30 days, assessment of Infarct size as a percent of area (myocardium) at risk,
Measured: 3 - 5 and 30 Days
30 Day Safety Endpoint Rates
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
Measured: 30 Days
Infarct Characteristics microvascular obstruction
Using CMR at 3-5 \& 30 days, measurement of percent of microvascular obstruction (%MVO)
Measured: 3-5 and 30 Days
Left Ventricular Function- LV end systolic and diastolic volume index
Using CMR imaging post PCI: assessment of LV end systolic and diastolic volume index (LVESVi \& LVEDVi)
Measured: 3-5 and 30 Days
Left Ventricular Function - Ejection Fraction
Using CMR at 3-5 \& 30 days post PCI: assessment of Ejection fraction (EF)
Measured: 3-5 and 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start11 Apr 2017
- Primary completion19 Jun 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by Abiomed Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000270
- Sponsor's protocol ID
- DTU - Safety and Feasibility
- Acronym
- DTU
- Status last verified
- Nov 2018
- First submitted
- 12 Dec 2016
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kapur NK, Alkhouli MA, DeMartini TJ, Faraz H, George ZH, Goodwin MJ, Hernandez-Montfort JA, Iyer VS, Josephy N, Kalra S, Kaki A, Karas RH, Kimmelstiel CD, Koenig GC, Lau E, Lotun K, Madder RD, Mannino SF, Meraj PM, Moreland JA, Moses JW, Kim RL, Schreiber TL, Udelson JE, Witzke C, Wohns DHW, O'Neill WW. Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction. Circulation. 2019 Jan 15;139(3):337-346. doi: 10.1161/CIRCULATIONAHA.118.038269.
PubMed 30586728
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study
- ClinicalTrials.gov ID
- NCT03000270
- Acronym / sponsor ID
- DTU / DTU - Safety and Feasibility
- Conditions
- STEMI
- Keywords
- Infarct Size, Impella, Unloading, Left Ventricle, PPCI, STEMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged unloading prior to PPCI | Active comparator | Device: Impella unloading prior to PPCIActivation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention |
| Immediate unloading prior to PPCI | Active comparator | Device: Impella unloading prior to PPCIActivation of Impella CP immediately prior to primary percutaneous coronary intervention |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impella unloading prior to PPCIImpella unloading prior to PPCI | Device | Immediate unloading prior to PPCI, Prolonged unloading prior to PPCI |
Primary outcome
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
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
6 secondary outcomes
Infarct Characteristics - LV mass
Time frame: 3 - 5 and 30 Days
Infarct Characteristics - area at risk
Time frame: 3 - 5 and 30 Days
30 Day Safety Endpoint Rates
Time frame: 30 Days
Infarct Characteristics microvascular obstruction
Time frame: 3-5 and 30 Days
Left Ventricular Function- LV end systolic and diastolic volume index
Time frame: 3-5 and 30 Days
Left Ventricular Function - Ejection Fraction
Time frame: 3-5 and 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Results publication: PubMed 30586728Kapur NK, Alkhouli MA, DeMartini TJ, Faraz H, George ZH, Goodwin MJ, Hernandez-Montfort JA, Iyer VS, Josephy N, Kalra S, Kaki A, Karas RH, Kimmelstiel CD, Koenig GC, Lau E, Lotun K, Madder RD, Mannino SF, Meraj PM, Moreland JA, Moses JW, Kim RL, Schreiber TL, Udelson JE, Witzke C, Wohns DHW, O'Neill WW. Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction. Circulation. 2019 Jan 15;139(3):337-346. doi: 10.1161/CIRCULATIONAHA.118.038269.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impella unloading prior to PPCI in people with STEMI, run by Abiomed Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size at 30 Days (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03000270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.