Myocardial InfarctionNCT01950130
Prophylactic IABP in High-risk Patients Undergoing CABG
A study testing Preoperative IABC in people with Myocardial Infarction and Coronary Artery Disease, run by University of Giessen at 1 site in Germany.
Trial summary
Due to advances and increased practice of interventional therapy for coronary artery disease, the rate of high-risk patients with severe coronary disease and reduced left ventricular function among patients undergoing coronary artery bypass grafting surgery (CABG) is increasing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- Preoperative IABC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodynamically stable high-risk patients before CABG, defined by the following criteria:
- Age >18 years
- Isolated CABG planned
- Informed consent in trial participation given
- Any left ventricular functional impairment (regional wall motion abnormality or global LVEF<55%) assessed via ventriculography or transthoracic or transeophageal echocardiography
- Elevated cardiac biomarkers (CK-MB > 6% of total-CK, Troponin I > 3-fold of specific test reference) or myocardial infarction (NSTEMI or STEMI) within the last 4 days.
Who cannot join
- Contraindications for IABP
- Cardiogenic shock
- Shock of any other cause
- Critical preoperative state according to EuroSCORE II-criteria
- Cardiac surgical procedure other than CABG planned
- Severe comorbidity with life expectancy < 6 months
- Incapability of giving informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Adult and Pediatric Cardiovascular Surgery
Giessen, 35392
About this study
Official title: Prophylactic Preoperative Inatraaortic Balloon Pump (IABP) in High-risk Patients Undergoing Coronary Artery Bypass Surgery (CABG)
Due to advances and increased practice of interventional therapy for coronary artery disease, the rate of high-risk patients with severe coronary disease and reduced left ventricular function among patients undergoing coronary artery bypass grafting surgery (CABG) is increasing. The perioperative mortality in these patients is ≥ 5%. The perioperative and operative management for these patients has to be optimized in order to reduce their perioperative morbidity and mortality. One of the central aspects is perioperative maintenance of hemodynamic stability. The use of prophylactic IABP is a partly established, but not sufficiently evidence-based measure to reduce ventricular afterload and improve coronary perfusion pre-, intra- and postoperatively. Yet, it is an invasive procedure with potential complications. The planned trial should give an explicit answer, whether preoperative prophylactic IABP decreases 30-day all-cause mortality (primary endpoint) and long-term mortality (3, 6, 12 months; secondary endpoints) compared to preoperative conservative treatment in high-risk patients undergoing CABG.
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Being tested
- Preoperative IABC
- Keywords
- IABP, IABC, coronary artery disease, prophylactic, cardiac assist
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative IABCProcedure or surgery
IABP-Insertion upon inclusion into the trial and admission to the ICU
| Study group | Role | What they receive |
|---|---|---|
| IABP group | Experimental | Preoperative IABP insertion Receives: Procedure: Preoperative IABC |
| Control group | No intervention | Preoperative conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality post CABG [%]
Measured: 30 days
Secondary outcomes (4)
Survival at 3, 6, 12 months [%]
Measured: 3, 6 and 12 months
Duration of ICU stay [h]
Measured: 48 hours (average)
Dependence on medical inotropic support
Measured: 48 hours (average)
IABP-associated complications
IABP-associated complications occur most often during IABP-support. However, after weaning from IABP, patients can still have bleeding complications or thrombembolic complications. Therefore, IABP-associated complications are monitored during the whole hospital stay
Measured: 8 days (average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startJun 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2018 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Philippe Grieshaber, University of Giessen
- Investigators
- Philippe Grieshaber, MD, Study director, Giessen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950130
- Sponsor's protocol ID
- A-1124
- Status last verified
- Nov 2021
- First submitted
- 18 Sep 2013
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Preoperative Inatraaortic Balloon Pump (IABP) in High-risk Patients Undergoing Coronary Artery Bypass Surgery (CABG)
- ClinicalTrials.gov ID
- NCT01950130
- Acronym / sponsor ID
- A-1124
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Keywords
- IABP, IABC, coronary artery disease, prophylactic, cardiac assist
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 25 Sep 2013 (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.
Due to advances and increased practice of interventional therapy for coronary artery disease, the rate of high-risk patients with severe coronary disease and reduced left ventricular function among patients undergoing coronary artery bypass grafting surgery (CABG) is increasing. The perioperative mortality in these patients is ≥ 5%. The perioperative and operative management for these patients has to be optimized in order to reduce their perioperative morbidity and mortality. One of the central aspects is perioperative maintenance of hemodynamic stability. The use of prophylactic IABP is a partly established, but not sufficiently evidence-based measure to reduce ventricular afterload and improve coronary perfusion pre-, intra- and postoperatively. Yet, it is an invasive procedure with potential complications. The planned trial should give an explicit answer, whether preoperative prophylactic IABP decreases 30-day all-cause mortality (primary endpoint) and long-term mortality (3, 6, 12 months; secondary endpoints) compared to preoperative conservative treatment in high-risk patients undergoing CABG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IABP group | Experimental | Procedure: Preoperative IABCPreoperative IABP insertion |
| Control group | No intervention | –Preoperative conservative treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years
- Isolated CABG planned
- Informed consent in trial participation given
- Any left ventricular functional impairment (regional wall motion abnormality or global LVEF<55%) assessed via ventriculography or transthoracic or transeophageal echocardiography
- Elevated cardiac biomarkers (CK-MB > 6% of total-CK, Troponin I > 3-fold of specific test reference) or myocardial infarction (NSTEMI or STEMI) within the last 4 days.
Key exclusion criteria (7 listed)
- Contraindications for IABP
- Cardiogenic shock
- Shock of any other cause
- Critical preoperative state according to EuroSCORE II-criteria
- Cardiac surgical procedure other than CABG planned
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 |
|---|---|---|
| Preoperative IABCIABP-Insertion upon inclusion into the trial and admission to the ICU | Procedure or surgery | IABP group |
Primary outcome
30-day all-cause mortality post CABG [%]
Time frame: 30 days
4 secondary outcomes
Survival at 3, 6, 12 months [%]
Time frame: 3, 6 and 12 months
Duration of ICU stay [h]
Time frame: 48 hours (average)
Dependence on medical inotropic support
Time frame: 48 hours (average)
IABP-associated complications
Time frame: 8 days (average)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
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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.
Philippe Grieshaber, MD study director
Giessen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative IABC in people with Myocardial Infarction and Coronary Artery Disease, run by University of Giessen at 1 site in Germany.
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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 22 Nov 2021. 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 Germany. 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 withdrawn before enrolling participants, so there are no results.
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?
30-day all-cause mortality post CABG [%] (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 22 Nov 2021.