Heart FailureRESCUENCT02790242
Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy
An observational study of Heart Failure and Cardiogenic Shock, run by Columbia University at 7 sites in United States.
Trial summary
The purpose of this study is to gather information on patients who have heart failure and are eligible for one of the following two procedures: 1) mechanical support, i.e. ventricular assist device (VAD) or 2) heart transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiogenic Shock
- How many people
- 1,089 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2013to 11 Feb 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential subjects include all adult patients who underwent evaluation for MCS for cardiogenic shock. Each adult patient who receives an MCSD at an institution will be screened according to the inclusion and exclusion criteria listed below.
Who may be able to join
- Adult patients who receive any MCSD including Veno-Arterial Extracorporeal Membrane Oxygenation (VA ECMO), surgical VAD, and percutaneous VAD, used to treat CS on or after 9/30/10. Intraaortic balloon pumping (IABP) is not considered an MCSD in this Registry.
- Adult patients who have signed informed consent. For patients who are too ill to give informed consent the health care proxy of the patient or next of kin will be approached for the informed consent.
Who cannot join
- patients younger than 18 years of age.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Colarodo
Aurora, Colorado, 80045
Duke University Medical Center
Durham, North Carolina, 27710
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Columbia University Irving Medical Center
New York, New York, 10032
Newark Beth Israel Medical center
Newark, New Jersey, 07112
Washington University
St Louis, Missouri, 63110
Westchester Medical Center
Valhalla, New York, 10595
About this study
The purpose of this study is to gather information on patients who have heart failure and are eligible for one of the following two procedures: 1) mechanical support, i.e. ventricular assist device (VAD) or 2) heart transplant. the study seeks to determine which patient populations benefit from heart transplant or ventricular assist device. This will allow to offer the state-of-the-art care to the patients in heart failure.
Read the detailed description
Cardiogenic shock (CS) develops in the end stage of various etiologies of heart failure and continues to hold high mortality; ranging from 50 to 80%. Expert consensus recommends use of more powerful mechanical circulatory support device (MCSD) in this patient population; however, scientific evidence has been anecdotal relying on mostly single-center small case series and, more fundamentally, because there is no unified definition to grade the severity of the highly heterogeneous condition CS. Well-designed studies are warranted to precisely characterize the various "phenotypes" of CS as well as the role of MCSD in this condition with still excessive mortality.
This multicenter registry will be the first multicenter large-scale registry focused on mechanical circulatory support (MCS) therapy for CS. The fundamental goal of RESCUE is to advance the understanding and application of MCSD in order to improve the persistently dismal survival of patients with CS with the following intents:
- Elucidate current indication and outcomes of MCSD use in CS.
- Redefine CS with better description of this disease entity, which will allow better prediction of outcomes, selection of treatment strategy, and comparison and design of studies.
- Facilitate the refinement of patient selection to maximize outcomes with current and new device options.
- Improve and expedite new device clinical trials by providing historical control data.
- Develop consensus "best practice" guidelines to improve clinical management by reducing short and long-term complications of MCSD therapy.
- Conditions
- Heart Failure, Cardiogenic Shock
- Keywords
- Mechanical Circulatory Support Device (MCSD), ventricular Assist Device (VAD)
- Medical subject headings
- Heart Failure, Shock, Cardiogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year survival post mechanical circulatory assist device implant
Measured: 12 months
Secondary outcomes (3)
survival to discharge post mechanical circulatory assist device implant
Measured: until the enrolled patient is discharged. Expected to occur within 90 days of enrollment.
30-day survival post mechanical circulatory assist device implant
Measured: 30 days
Number of adverse events during mechanical circulatory assist device support
Measured: up to 30-days of weaning from the device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startNov 2013
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,089 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hiroo Takayama, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790242
- Sponsor's protocol ID
- AAAM2960
- Acronym
- RESCUE
- Status last verified
- Apr 2023
- First submitted
- 31 May 2016
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. doi: 10.1056/NEJM199908263410901.
PubMed 10460813Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26.
PubMed 22920912Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Baldwin JT, Young JB. Fifth INTERMACS annual report: risk factor analysis from more than 6,000 mechanical circulatory support patients. J Heart Lung Transplant. 2013 Feb;32(2):141-56. doi: 10.1016/j.healun.2012.12.004.
PubMed 23352390Kirklin JK, Naftel DC, Pagani FD, Kormos RL, Stevenson L, Miller M, Young JB. Long-term mechanical circulatory support (destination therapy): on track to compete with heart transplantation? J Thorac Cardiovasc Surg. 2012 Sep;144(3):584-603; discussion 597-8. doi: 10.1016/j.jtcvs.2012.05.044. Epub 2012 Jul 15.
PubMed 22795459O'Connor CM, Rogers JG. Evidence for overturning the guidelines in cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1349-50. doi: 10.1056/NEJMe1209601. Epub 2012 Aug 26. No abstract available.
PubMed 22920913
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy
- ClinicalTrials.gov ID
- NCT02790242
- Acronym / sponsor ID
- RESCUE / AAAM2960
- Conditions
- Heart Failure, Cardiogenic Shock
- Keywords
- Mechanical Circulatory Support Device (MCSD), ventricular Assist Device (VAD)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 1,089 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 3 Jun 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.
The purpose of this study is to gather information on patients who have heart failure and are eligible for one of the following two procedures: 1) mechanical support, i.e. ventricular assist device (VAD) or 2) heart transplant. the study seeks to determine which patient populations benefit from heart transplant or ventricular assist device. This will allow to offer the state-of-the-art care to the patients in heart failure.
Detailed description
Cardiogenic shock (CS) develops in the end stage of various etiologies of heart failure and continues to hold high mortality; ranging from 50 to 80%. Expert consensus recommends use of more powerful mechanical circulatory support device (MCSD) in this patient population; however, scientific evidence has been anecdotal relying on mostly single-center small case series and, more fundamentally, because there is no unified definition to grade the severity of the highly heterogeneous condition CS. Well-designed studies are warranted to precisely characterize the various "phenotypes" of CS as well as the role of MCSD in this condition with still excessive mortality.
This multicenter registry will be the first multicenter large-scale registry focused on mechanical circulatory support (MCS) therapy for CS. The fundamental goal of RESCUE is to advance the understanding and application of MCSD in order to improve the persistently dismal survival of patients with CS with the following intents:
- Elucidate current indication and outcomes of MCSD use in CS.
- Redefine CS with better description of this disease entity, which will allow better prediction of outcomes, selection of treatment strategy, and comparison and design of studies.
- Facilitate the refinement of patient selection to maximize outcomes with current and new device options.
- Improve and expedite new device clinical trials by providing historical control data.
- Develop consensus "best practice" guidelines to improve clinical management by reducing short and long-term complications of MCSD therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential subjects include all adult patients who underwent evaluation for MCS for cardiogenic shock. Each adult patient who receives an MCSD at an institution will be screened according to the inclusion and exclusion criteria listed below.
Key inclusion criteria (2 listed)
- Adult patients who receive any MCSD including Veno-Arterial Extracorporeal Membrane Oxygenation (VA ECMO), surgical VAD, and percutaneous VAD, used to treat CS on or after 9/30/10. Intraaortic balloon pumping (IABP) is not considered an MCSD in this Registry.
- Adult patients who have signed informed consent. For patients who are too ill to give informed consent the health care proxy of the patient or next of kin will be approached for the informed consent.
Key exclusion criteria (1 listed)
- patients younger than 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1-year survival post mechanical circulatory assist device implant
Time frame: 12 months
3 secondary outcomes
survival to discharge post mechanical circulatory assist device implant
Time frame: until the enrolled patient is discharged. Expected to occur within 90 days of enrollment.
30-day survival post mechanical circulatory assist device implant
Time frame: 30 days
Number of adverse events during mechanical circulatory assist device support
Time frame: up to 30-days of weaning from the device.
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 10460813Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. doi: 10.1056/NEJM199908263410901.
- Background: PubMed 22920912Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26.
- Background: PubMed 23352390Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Baldwin JT, Young JB. Fifth INTERMACS annual report: risk factor analysis from more than 6,000 mechanical circulatory support patients. J Heart Lung Transplant. 2013 Feb;32(2):141-56. doi: 10.1016/j.healun.2012.12.004.
- Background: PubMed 22795459Kirklin JK, Naftel DC, Pagani FD, Kormos RL, Stevenson L, Miller M, Young JB. Long-term mechanical circulatory support (destination therapy): on track to compete with heart transplantation? J Thorac Cardiovasc Surg. 2012 Sep;144(3):584-603; discussion 597-8. doi: 10.1016/j.jtcvs.2012.05.044. Epub 2012 Jul 15.
- Background: PubMed 22920913O'Connor CM, Rogers JG. Evidence for overturning the guidelines in cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1349-50. doi: 10.1056/NEJMe1209601. Epub 2012 Aug 26. No abstract available.
- 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.
Hiroo Takayama, MD, PhD principal investigator
Columbia University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiogenic Shock, run by Columbia University at 7 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?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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: stopped early, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 was stopped early (reason given: Lack of funding). Results are not available in the source record.
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?
1-year survival post mechanical circulatory assist device implant (time frame: 12 months). 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 NCT02790242, which also lists 5 linked publications.
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 13 Apr 2023.