Post-Cardiac Arrest SyndromeNCT03638609
The Effect of IABP Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome
A study testing Intra Aortic Balloon Pump in people with Post-Cardiac Arrest Syndrome, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The prevalence of cardiac arrests is still high worldwide. Despite the return of spontaneous circulation (ROSC), mortality and morbidity in post cardiac arrest patients is reported high. Comprehensive management is essential in treating patients with post cardiac arrest syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Cardiac Arrest Syndrome
- What is being tested?
- Intra Aortic Balloon Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Oct 2017to 23 Nov 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 and less than 75 years.
- Post cardiac arrest syndrome patients with decreased level of consciousness (cerebral performance categories (CPC) more than 1) and hypotension (systolic blood pressure less than 100)
- Experiencing successful cardiac rescucitation following cardiac arrest
Who cannot join
- History of stroke (based on interview)
- Unequal pupil
- Previous use of IABP
- Aorta regurgitation
- Brugada syndrome and congenital long QT
- Drop-out Criteria:
Show all 10Show fewer
- Participants who died before IABP insertion
- The family requests for a termination of treatment.
- Anemia caused by bleeding with hemoglobin decrement by >3 gr/dL
- Ankle brachial index(ABI) less than 0,8
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
National Cradiovascular Center Harapan Kita Hospital
Jakarta, 11420
Isman Firdaus, MD, +621-5684093 ext. 1265, ismanf@yahoo.com
Gloria Kartika, MD, +621-5684093 ext. 1265, gloria_kartika@yahoo.com
About this study
Official title: The Effect of Intra Aortic Balloon Pump Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome
The prevalence of cardiac arrests is still high worldwide. Despite the return of spontaneous circulation (ROSC), mortality and morbidity in post cardiac arrest patients is reported high. Comprehensive management is essential in treating patients with post cardiac arrest syndrome. Adequate circulatory stability is achieved with fluid therapy, vasoactive drug therapy, and consideration of mechanical support. Intra-Aortic Ballon Pump (IABP) is one of the most feasible and available mechanical support in developing countries including Indonesia.
There are several benefits of IABP reported in acute myocardial infarction complicated with cardiogenic shock. Nevertheless, the IABP-SHOCK II study revealed contradictive result which is IABP support was not improving mortality in acute myocardial infarction complicated with cardiogenic shock after revascularization. Other study, Korean Acute Myocardial Infarction Registry (KAMIR), also reported no benefits of IABP support in cardiogenic shock patients. But, the study the investigators mentioned earlier is a registry study, attributed to selection bias and several confounding factors resulting mismatch in population. There are no consideration to IABP time of initiation and duration of use in both studies.
The Investigator is aiming to prove the early insertion of IABP to a better outcome compared with the absence of early IABP. The objective of the study is to assess mortality in post cardiac arrest syndrome patients with early insertion of IABP support. A total of 102 subjects will be enrolled in this study, divided into IABP and non-IABP group. The primary outcome is in-hopital-mortality, and various indicators in the pathomechanisme of post cardiac arrest syndrome will be measured in 30 minutes and 6 hours after ROSC. Effective lactate clearance, IL-6, Beclin-1, Caspase-3, a-vO2 diff, and ScvO2, cardiac output, VTI, TAPSE and ejection fraction will be measured and analized between the two groups.
- Conditions
- Post-Cardiac Arrest Syndrome
- Being tested
- Intra Aortic Balloon Pump
- Keywords
- IABP, Post-Cardiac Arrest Syndrome, Beclin-1, Caspase-3, Mortality
- Medical subject headings
- Post-Cardiac Arrest Syndrome, Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra Aortic Balloon PumpDevice
Also called IABP
Intra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle. It is indicated as supportive therapy for patients undergoing revascularization, cardiogenic shock and mechanical complication.
Balloon dilatation during dyastolic phase increasing dyastolic pressure in aorta, improving coronary vascularization and myocardial oxygen supply. In systolic phase, the balloon deflates, reducing the left ventricle afterload hence decreasing myocardial oxygen demand.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Group of patients not receiving IABP |
| Intra Aortic Balloon Pump | Experimental | Group of patients receiving Intra Aortic Balloon Pump in 3 hours after ROSC (early insertion of IABP) Receives: Device: Intra Aortic Balloon Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Hospital Mortality
Mortality of patients during the hospitalization receiving early insertion IABP
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 posted20 Aug 2018
- Study start23 Oct 2017
- Primary completion23 Oct 2018 (estimated)
- Study completion23 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Post-Cardiac Arrest SyndromeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Responsible party
- Principal investigator, Isman Firdaus, MD, Universitas Indonesia
- Investigators
- Isman Firdaus, MD, Principal investigator, National Cardiovascular Center Harapan Kita Hospital Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638609
- Sponsor's protocol ID
- IABP17
- Status last verified
- Aug 2018
- First submitted
- 9 Aug 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Adams JA, Uryash A, Nadkarni V, Berg RA, Lopez JR. Whole body periodic acceleration (pGz) preserves heart rate variability after cardiac arrest. Resuscitation. 2016 Feb;99:20-5. doi: 10.1016/j.resuscitation.2015.11.018. Epub 2015 Dec 12.
PubMed 26690649Neumar RW, Nolan JP, Adrie C, Aibiki M, Berg RA, Bottiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT Jr, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Vanden Hoek T. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. A consensus statement from the International Liaison Committee on Resuscitation (American Heart Association, Australian and New Zealand Council on Resuscitation, European Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Asia, and the Resuscitation Council of Southern Africa); the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; and the Stroke Council. Circulation. 2008 Dec 2;118(23):2452-83. doi: 10.1161/CIRCULATIONAHA.108.190652. Epub 2008 Oct 23. No abstract available.
PubMed 18948368Stub D, Bernard S, Duffy SJ, Kaye DM. Post cardiac arrest syndrome: a review of therapeutic strategies. Circulation. 2011 Apr 5;123(13):1428-35. doi: 10.1161/CIRCULATIONAHA.110.988725. No abstract available.
PubMed 21464058Firdaus I. Registry of Acute and Intensive Cardiovascular Care on Outcome (RAICOM) in National Cardiovascular Center Harapan Kita Indonesia. 2016.
iSTEMI (Indonesia STEMI). 2016
Jentzer JC, Chonde MD, Dezfulian C. Myocardial Dysfunction and Shock after Cardiac Arrest. Biomed Res Int. 2015;2015:314796. doi: 10.1155/2015/314796. Epub 2015 Sep 2.
PubMed 26421284Mongardon N, Dumas F, Ricome S, Grimaldi D, Hissem T, Pene F, Cariou A. Postcardiac arrest syndrome: from immediate resuscitation to long-term outcome. Ann Intensive Care. 2011 Nov 3;1(1):45. doi: 10.1186/2110-5820-1-45.
PubMed 22053891Pellis T, Sanfilippo F, Ristagno G. The optimal hemodynamics management of post-cardiac arrest shock. Best Pract Res Clin Anaesthesiol. 2015 Dec;29(4):485-95. doi: 10.1016/j.bpa.2015.10.002. Epub 2015 Oct 14.
PubMed 26670819He C, Levine B. The Beclin 1 interactome. Curr Opin Cell Biol. 2010 Apr;22(2):140-9. doi: 10.1016/j.ceb.2010.01.001. Epub 2010 Jan 22.
PubMed 20097051Kang R, Zeh HJ, Lotze MT, Tang D. The Beclin 1 network regulates autophagy and apoptosis. Cell Death Differ. 2011 Apr;18(4):571-80. doi: 10.1038/cdd.2010.191. Epub 2011 Feb 11.
PubMed 21311563Green DR, Llambi F. Cell Death Signaling. Cold Spring Harb Perspect Biol. 2015 Dec 1;7(12):a006080. doi: 10.1101/cshperspect.a006080.
PubMed 26626938McIlwain DR, Berger T, Mak TW. Caspase functions in cell death and disease. Cold Spring Harb Perspect Biol. 2013 Apr 1;5(4):a008656. doi: 10.1101/cshperspect.a008656.
PubMed 23545416Brentnall M, Rodriguez-Menocal L, De Guevara RL, Cepero E, Boise LH. Caspase-9, caspase-3 and caspase-7 have distinct roles during intrinsic apoptosis. BMC Cell Biol. 2013 Jul 9;14:32. doi: 10.1186/1471-2121-14-32.
PubMed 23834359Porter AG, Janicke RU. Emerging roles of caspase-3 in apoptosis. Cell Death Differ. 1999 Feb;6(2):99-104. doi: 10.1038/sj.cdd.4400476.
PubMed 10200555Jahania SM, Sengstock D, Vaitkevicius P, Andres A, Ito BR, Gottlieb RA, Mentzer RM Jr. Activation of the homeostatic intracellular repair response during cardiac surgery. J Am Coll Surg. 2013 Apr;216(4):719-26; discussion 726-9. doi: 10.1016/j.jamcollsurg.2012.12.034. Epub 2013 Feb 13.
PubMed 23415552
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intra Aortic Balloon Pump Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03638609
- Acronym / sponsor ID
- IABP17
- Conditions
- Post-Cardiac Arrest Syndrome
- Keywords
- IABP, Post-Cardiac Arrest Syndrome, Beclin-1, Caspase-3, Mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 23 Oct 2018 (estimated)
- Study completion
- 23 Nov 2018 (estimated)
- First posted
- 20 Aug 2018 (actual)
- 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 prevalence of cardiac arrests is still high worldwide. Despite the return of spontaneous circulation (ROSC), mortality and morbidity in post cardiac arrest patients is reported high. Comprehensive management is essential in treating patients with post cardiac arrest syndrome. Adequate circulatory stability is achieved with fluid therapy, vasoactive drug therapy, and consideration of mechanical support. Intra-Aortic Ballon Pump (IABP) is one of the most feasible and available mechanical support in developing countries including Indonesia.
There are several benefits of IABP reported in acute myocardial infarction complicated with cardiogenic shock. Nevertheless, the IABP-SHOCK II study revealed contradictive result which is IABP support was not improving mortality in acute myocardial infarction complicated with cardiogenic shock after revascularization. Other study, Korean Acute Myocardial Infarction Registry (KAMIR), also reported no benefits of IABP support in cardiogenic shock patients. But, the study the investigators mentioned earlier is a registry study, attributed to selection bias and several confounding factors resulting mismatch in population. There are no consideration to IABP time of initiation and duration of use in both studies.
The Investigator is aiming to prove the early insertion of IABP to a better outcome compared with the absence of early IABP. The objective of the study is to assess mortality in post cardiac arrest syndrome patients with early insertion of IABP support. A total of 102 subjects will be enrolled in this study, divided into IABP and non-IABP group. The primary outcome is in-hopital-mortality, and various indicators in the pathomechanisme of post cardiac arrest syndrome will be measured in 30 minutes and 6 hours after ROSC. Effective lactate clearance, IL-6, Beclin-1, Caspase-3, a-vO2 diff, and ScvO2, cardiac output, VTI, TAPSE and ejection fraction will be measured and analized between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Group of patients not receiving IABP |
| Intra Aortic Balloon Pump | Experimental | Device: Intra Aortic Balloon PumpGroup of patients receiving Intra Aortic Balloon Pump in 3 hours after ROSC (early insertion of IABP) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 and less than 75 years.
- Post cardiac arrest syndrome patients with decreased level of consciousness (cerebral performance categories (CPC) more than 1) and hypotension (systolic blood pressure less than 100)
- Experiencing successful cardiac rescucitation following cardiac arrest
Key exclusion criteria (10 listed)
- History of stroke (based on interview)
- Unequal pupil
- Previous use of IABP
- Aorta regurgitation
- Brugada syndrome and congenital long QT
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 |
|---|---|---|
| Intra Aortic Balloon PumpAlso: IABPIntra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle. It is indicated as supportive therapy for patients undergoing revascularization, cardiogenic shock and mechanical complication. Balloon dilatation during dyastolic phase increasing dyastolic pressure in aorta, improving coronary vascularization and myocardial oxygen supply. In systolic phase, the balloon deflates, reducing the left ventricle afterload hence decreasing myocardial oxygen demand. | Device | Intra Aortic Balloon Pump |
Primary outcome
In-Hospital Mortality
Time frame: 30 days
Mortality of patients during the hospitalization receiving early insertion IABP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Background: PubMed 26690649Adams JA, Uryash A, Nadkarni V, Berg RA, Lopez JR. Whole body periodic acceleration (pGz) preserves heart rate variability after cardiac arrest. Resuscitation. 2016 Feb;99:20-5. doi: 10.1016/j.resuscitation.2015.11.018. Epub 2015 Dec 12.
- Background: PubMed 18948368Neumar RW, Nolan JP, Adrie C, Aibiki M, Berg RA, Bottiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT Jr, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Vanden Hoek T. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. A consensus statement from the International Liaison Committee on Resuscitation (American Heart Association, Australian and New Zealand Council on Resuscitation, European Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Asia, and the Resuscitation Council of Southern Africa); the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; and the Stroke Council. Circulation. 2008 Dec 2;118(23):2452-83. doi: 10.1161/CIRCULATIONAHA.108.190652. Epub 2008 Oct 23. No abstract available.
- Background: PubMed 21464058Stub D, Bernard S, Duffy SJ, Kaye DM. Post cardiac arrest syndrome: a review of therapeutic strategies. Circulation. 2011 Apr 5;123(13):1428-35. doi: 10.1161/CIRCULATIONAHA.110.988725. No abstract available.
- BackgroundFirdaus I. Registry of Acute and Intensive Cardiovascular Care on Outcome (RAICOM) in National Cardiovascular Center Harapan Kita Indonesia. 2016.
- BackgroundiSTEMI (Indonesia STEMI). 2016
- Background: PubMed 26421284Jentzer JC, Chonde MD, Dezfulian C. Myocardial Dysfunction and Shock after Cardiac Arrest. Biomed Res Int. 2015;2015:314796. doi: 10.1155/2015/314796. Epub 2015 Sep 2.
- Background: PubMed 22053891Mongardon N, Dumas F, Ricome S, Grimaldi D, Hissem T, Pene F, Cariou A. Postcardiac arrest syndrome: from immediate resuscitation to long-term outcome. Ann Intensive Care. 2011 Nov 3;1(1):45. doi: 10.1186/2110-5820-1-45.
- Background: PubMed 26670819Pellis T, Sanfilippo F, Ristagno G. The optimal hemodynamics management of post-cardiac arrest shock. Best Pract Res Clin Anaesthesiol. 2015 Dec;29(4):485-95. doi: 10.1016/j.bpa.2015.10.002. Epub 2015 Oct 14.
- Background: PubMed 20097051He C, Levine B. The Beclin 1 interactome. Curr Opin Cell Biol. 2010 Apr;22(2):140-9. doi: 10.1016/j.ceb.2010.01.001. Epub 2010 Jan 22.
- Background: PubMed 21311563Kang R, Zeh HJ, Lotze MT, Tang D. The Beclin 1 network regulates autophagy and apoptosis. Cell Death Differ. 2011 Apr;18(4):571-80. doi: 10.1038/cdd.2010.191. Epub 2011 Feb 11.
- Background: PubMed 26626938Green DR, Llambi F. Cell Death Signaling. Cold Spring Harb Perspect Biol. 2015 Dec 1;7(12):a006080. doi: 10.1101/cshperspect.a006080.
- Background: PubMed 23545416McIlwain DR, Berger T, Mak TW. Caspase functions in cell death and disease. Cold Spring Harb Perspect Biol. 2013 Apr 1;5(4):a008656. doi: 10.1101/cshperspect.a008656.
- Individual participant dataSharing planned: Undecided
Related trials for Post-Cardiac Arrest Syndrome
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
Recruiting
Cerebral Oximetry in Management of Post Cardiac Arrest
Post-Cardiac Arrest Syndrome, Post Cardiac Arrest Brain Injury
Active, not recruitingObservational study
Multiomics Profiling of CSF in Cardiac Arrest Survivors
Cardiac Arrest (CA), Hypoxic-Ischemic Brain Injury
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.
Isman Firdaus, MD principal investigator
National Cardiovascular Center Harapan Kita Hospital Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra Aortic Balloon Pump in people with Post-Cardiac Arrest Syndrome, run by Universitas Indonesia at 1 site in Indonesia.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Aug 2018. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isman Firdaus, MD (+621-5684093 ext. 1265, ismanf@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-Hospital Mortality (time frame: 30 days). 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 NCT03638609, which also lists 30 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 20 Aug 2018.