Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac SurgeryPhase 4ACTIONSNCT01253356
ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery
A Phase 4 study testing IABP in people with Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery, run by Datascope Corp. at 1 site in United States.
Trial summary
The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30 days compared with standard care alone, while maintaining acceptable safety with respect to vascular accesss-related complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery
- What is being tested?
- IABP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Feb 2012
- Phase
- Phase 4
- 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
Who may be able to join
- Patients > 18 years with planned elective major abdominal, noncardiac thoracic, head and neck, vascular, or orthopedic surgery and guideline-treated iscehmic heart disease with left ventricular dysfunction (systolic ejection fraction < or = 30%)
Who cannot join
- Unstable coronary syndromes Decompensated or NYHA Class IV heart failure Hemodynamic instability Cardiac biomarker instability Need for surgical procedure interfering with placement of IABP Cardiogenic shock Septic shock Contraindication to IABP use Clinical need for IABP ASA score > or = 5 Pregnancy Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Controlled Pilot Study of Intra-Aortic Balloon Counterpulsation to Prevent Perioperative Cardiac Events in High-Risk Cardiac Patients Undergoing Noncardiac Surgery
The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30 days compared with standard care alone, while maintaining acceptable safety with respect to vascular accesss-related complications.
- Conditions
- Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery
- Being tested
- IABP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IABPDevice
Insertion of intra-aortic balloon < or = 3 hours before noncardiac surgery and maintained > or = 12-24 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| No IABP | No intervention | Standard of care and no IABP |
| Intra-Aortic Balloon Pump (IABP) | Active comparator | Standard of care, IABP inserted < or = 3 hours before noncardiac surgery, maintained for > or = 12-24 hours after surgery Receives: Device: IABP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Amputation, Clinically significant bleeding, Vascular complications
Measured: 30 days
Secondary outcomes (1)
Efficacy
A composite of the following:
All-cause mortality, Cardiovascular mortality, Hemorrhagic or ischemic stroke, New nonfatal myocardial infarction, New or worsening congestive heart failure, Hemodynamically significant arrhythmia requiring intervention
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionFeb 2012 (estimated)
Why it stopped: Only 1 patient recruited and deemed ineligible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac SurgeryStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Datascope Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Don Poldermans, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253356
- Sponsor's protocol ID
- P-00002
- Acronym
- ACTIONS
- Status last verified
- Jan 2012
- First submitted
- 2 Dec 2010
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Pilot Study of Intra-Aortic Balloon Counterpulsation to Prevent Perioperative Cardiac Events in High-Risk Cardiac Patients Undergoing Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT01253356
- Acronym / sponsor ID
- ACTIONS / P-00002
- Conditions
- Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only 1 patient recruited and deemed ineligible.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Datascope Corp.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 3 Dec 2010 (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 use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30 days compared with standard care alone, while maintaining acceptable safety with respect to vascular accesss-related complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No IABP | No intervention | –Standard of care and no IABP |
| Intra-Aortic Balloon Pump (IABP) | Active comparator | Device: IABPStandard of care, IABP inserted < or = 3 hours before noncardiac surgery, maintained for > or = 12-24 hours after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients > 18 years with planned elective major abdominal, noncardiac thoracic, head and neck, vascular, or orthopedic surgery and guideline-treated iscehmic heart disease with left ventricular dysfunction (systolic ejection fraction < or = 30%)
Key exclusion criteria (1 listed)
- Unstable coronary syndromes Decompensated or NYHA Class IV heart failure Hemodynamic instability Cardiac biomarker instability Need for surgical procedure interfering with placement of IABP Cardiogenic shock Septic shock Contraindication to IABP use Clinical need for IABP ASA score > or = 5 Pregnancy Inability to provide informed consent
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 |
|---|---|---|
| IABPInsertion of intra-aortic balloon < or = 3 hours before noncardiac surgery and maintained > or = 12-24 hours after surgery | Device | Intra-Aortic Balloon Pump (IABP) |
Primary outcome
Safety
Time frame: 30 days
Amputation, Clinically significant bleeding, Vascular complications
1 secondary outcome
Efficacy
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Only 1 patient recruited and deemed ineligible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
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.
Don Poldermans, MD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IABP in people with Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery, run by Datascope Corp. at 1 site 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 1 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 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Only 1 patient recruited and deemed ineligible.). 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?
Safety (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2012.