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Out-Of-Hospital Cardiac ArrestNCT03093948

Effect of Remote Ischemic Post-conditioning on Out-of-hospital Cardiac Arrest

A study testing Remote ischemic post-conditioning in people with Out-Of-Hospital Cardiac Arrest, run by Chonnam National University Hospital at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Ischemia-reperfusion leads to mitochondrial injury, ion-pump injury, cell membrane damage, cytotoxic edema, and excessive oxygen free radical formation, and eventually destroys cells. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Out-Of-Hospital Cardiac Arrest
What is being tested?
Remote ischemic post-conditioning
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteSouth Korea
Study dates
21 Mar 2017to 21 Oct 2019
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (19 years and older)
  • comatose out-of-hospital cardiac arrest with sustained restoration of spontaneous circulation
  • Undergoing targeted temperature management
  • Time of enrollment ≤ 6hrs from restoration of spontaneous circulation
  • cardiac arrest from medical cause (cardiac or other medical cause)

Who cannot join

  • Pre-existing dementia, brain injury, or dependence on others (cerebral performance category scale greater than 3)
  • Traumatic etiology for cardiac arrest
  • Protected population (pregnant, prisoner)
  • in-hospital cardiac arrest
  • Known bleeding diathesis
  • suspected or confirmed acute intracranial hemorrhage
Show all 13Show fewer
  • suspected or confirmed acute ischemic stroke
  • Known limitations in therapy and do-not-resuscitate order
  • known disease making 180-day survival unlikely
  • >6 hours from restoration of spontaneous circulation to randomization
  • cardiac arrest from asphyxia (hanging, foreign body airway obstruction), drowning, drug overdose, or electrocution
  • peripheral vascular disease (Deep vein thrombosis, arteriosclerosis obliterans)
  • systolic blood pressure < 80 mmHg in spite of fluid loading/vasopressor and/or inotropic medication

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Chonnam National University Hospital

    Gwangju

Other trials in South Korea

About this study

Official title: Effect of Remote Ischemic Post-conditioning on Neurologic and Cardiac Recovery in Out-of-hospital Cardiac Arrest

Ischemia-reperfusion leads to mitochondrial injury, ion-pump injury, cell membrane damage, cytotoxic edema, and excessive oxygen free radical formation, and eventually destroys cells. Cardiac arrest is an example of global ischemia; after spontaneous circulation is restored, ischemia-reperfusion injury develops in cardiac arrest survivors.

Remote ischemic postconditioning (RIPoC) involves the application of brief, reversible episodes of ischemia and reperfusion to a vascular bed or tissue, rendering remote tissues and organs resistant to ischemia-reperfusion injury. Accordingly, RIPoC has been suggested as adjunctive therapy to mitigate ischemia-reperfusion injury. RIPoC applied by repeated brief inflation-deflation of a blood pressure cuff protects against myocardial injury, and has been proven effective in acute myocardial infarction.

Read more

This study aims to perform a randomized controlled trial to determine whether RIPoC has a neuroprotective effect and aids in myocardial recovery in out-of-hospital cardiac arrest patients after restoration of spontaneous circulation.

Neuron-specific enolase (NSE) at 48 hours after restoration of spontaneous circulation will be measured as a primary outcome.

Being tested
Remote ischemic post-conditioning
Medical subject headings
Out-of-Hospital Cardiac Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote ischemic post-conditioningProcedure or surgery

    Remote ischemic post-conditioning will undergo in both thighs at the beginning of targeted temperature management. This will be done with noninvasive measurement of blood pressure, with cuffs inflated to 200 mmHg for four 5 min cycles and interrupted three times for 5 min with cuff deflation.

Study groups in NCT03093948
Study groupRoleWhat they receive
Remote Ischemic post-conditioningExperimentalNot described
Receives: Procedure: Remote ischemic post-conditioning
standard of careNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. neuron specific enolase

    expressed in ng/ml

    Measured: at 48 hour after restoration of spontaneous circulation

Secondary outcomes (3)
  1. change over troponin-I

    troponin-I will be expressed in ng/ml

    Measured: at 24 hour and 48 hour after restoration of spontaneous circulation

  2. change over creatinin kinase-MB

    CK-MB will be expressed in ng/ml

    Measured: at 24 hour and 48 hour after restoration of spontaneous circulation

  3. neurologic outcome

    cerebral performance category scale 1, 2, 3, 4, 5

    Measured: an average of 3 weeks after restoration of spontaneous circulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2017
  2. Study start21 Mar 2017
  3. Primary completion21 Oct 2019
  4. Study completion21 Oct 2019

Why it stopped: Overlap with other RCT

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03093948
Sponsor's protocol ID
CNUH-2017-051
Status last verified
Jan 2021
First submitted
17 Mar 2017
Last updated
27 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • McNally B, Robb R, Mehta M, Vellano K, Valderrama AL, Yoon PW, Sasson C, Crouch A, Perez AB, Merritt R, Kellermann A; Centers for Disease Control and Prevention. Out-of-hospital cardiac arrest surveillance --- Cardiac Arrest Registry to Enhance Survival (CARES), United States, October 1, 2005--December 31, 2010. MMWR Surveill Summ. 2011 Jul 29;60(8):1-19.

    PubMed 21796098
  • Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15.

    PubMed 21160056
  • Iliodromitis EK, Kyrzopoulos S, Paraskevaidis IA, Kolocassides KG, Adamopoulos S, Karavolias G, Kremastinos DT. Increased C reactive protein and cardiac enzyme levels after coronary stent implantation. Is there protection by remote ischaemic preconditioning? Heart. 2006 Dec;92(12):1821-6. doi: 10.1136/hrt.2006.089060. Epub 2006 Jul 19.

    PubMed 16855045
  • Hoole SP, Heck PM, Sharples L, Khan SN, Duehmke R, Densem CG, Clarke SC, Shapiro LM, Schofield PM, O'Sullivan M, Dutka DP. Cardiac Remote Ischemic Preconditioning in Coronary Stenting (CRISP Stent) Study: a prospective, randomized control trial. Circulation. 2009 Feb 17;119(6):820-7. doi: 10.1161/CIRCULATIONAHA.108.809723. Epub 2009 Feb 2.

    PubMed 19188504
  • Davies WR, Brown AJ, Watson W, McCormick LM, West NE, Dutka DP, Hoole SP. Remote ischemic preconditioning improves outcome at 6 years after elective percutaneous coronary intervention: the CRISP stent trial long-term follow-up. Circ Cardiovasc Interv. 2013 Jun;6(3):246-51. doi: 10.1161/CIRCINTERVENTIONS.112.000184. Epub 2013 May 21.

    PubMed 23696599
  • Ahmed RM, Mohamed el-HA, Ashraf M, Maithili S, Nabil F, Rami R, Mohamed TI. Effect of remote ischemic preconditioning on serum troponin T level following elective percutaneous coronary intervention. Catheter Cardiovasc Interv. 2013 Nov 1;82(5):E647-53. doi: 10.1002/ccd.24825. Epub 2013 Jun 18.

    PubMed 23404916
  • Prasad A, Gossl M, Hoyt J, Lennon RJ, Polk L, Simari R, Holmes DR Jr, Rihal CS, Lerman A. Remote ischemic preconditioning immediately before percutaneous coronary intervention does not impact myocardial necrosis, inflammatory response, and circulating endothelial progenitor cell counts: a single center randomized sham controlled trial. Catheter Cardiovasc Interv. 2013 May;81(6):930-6. doi: 10.1002/ccd.24443. Epub 2012 Nov 8.

    PubMed 22517646
  • Luo SJ, Zhou YJ, Shi DM, Ge HL, Wang JL, Liu RF. Remote ischemic preconditioning reduces myocardial injury in patients undergoing coronary stent implantation. Can J Cardiol. 2013 Sep;29(9):1084-9. doi: 10.1016/j.cjca.2012.11.022. Epub 2013 Feb 12.

    PubMed 23414904
  • Xu X, Zhou Y, Luo S, Zhang W, Zhao Y, Yu M, Ma Q, Gao F, Shen H, Zhang J. Effect of remote ischemic preconditioning in the elderly patients with coronary artery disease with diabetes mellitus undergoing elective drug-eluting stent implantation. Angiology. 2014 Sep;65(8):660-6. doi: 10.1177/0003319713507332. Epub 2013 Oct 24.

    PubMed 24163121
  • Zografos TA, Katritsis GD, Tsiafoutis I, Bourboulis N, Katsivas A, Katritsis DG. Effect of one-cycle remote ischemic preconditioning to reduce myocardial injury during percutaneous coronary intervention. Am J Cardiol. 2014 Jun 15;113(12):2013-7. doi: 10.1016/j.amjcard.2014.03.043. Epub 2014 Apr 1.

    PubMed 24793669
  • Munk K, Andersen NH, Schmidt MR, Nielsen SS, Terkelsen CJ, Sloth E, Botker HE, Nielsen TT, Poulsen SH. Remote Ischemic Conditioning in Patients With Myocardial Infarction Treated With Primary Angioplasty: Impact on Left Ventricular Function Assessed by Comprehensive Echocardiography and Gated Single-Photon Emission CT. Circ Cardiovasc Imaging. 2010 Nov;3(6):656-62. doi: 10.1161/CIRCIMAGING.110.957340. Epub 2010 Sep 8.

    PubMed 20826592
  • Rentoukas I, Giannopoulos G, Kaoukis A, Kossyvakis C, Raisakis K, Driva M, Panagopoulou V, Tsarouchas K, Vavetsi S, Pyrgakis V, Deftereos S. Cardioprotective role of remote ischemic periconditioning in primary percutaneous coronary intervention: enhancement by opioid action. JACC Cardiovasc Interv. 2010 Jan;3(1):49-55. doi: 10.1016/j.jcin.2009.10.015.

    PubMed 20129568
  • Crimi G, Pica S, Raineri C, Bramucci E, De Ferrari GM, Klersy C, Ferlini M, Marinoni B, Repetto A, Romeo M, Rosti V, Massa M, Raisaro A, Leonardi S, Rubartelli P, Oltrona Visconti L, Ferrario M. Remote ischemic post-conditioning of the lower limb during primary percutaneous coronary intervention safely reduces enzymatic infarct size in anterior myocardial infarction: a randomized controlled trial. JACC Cardiovasc Interv. 2013 Oct;6(10):1055-63. doi: 10.1016/j.jcin.2013.05.011.

    PubMed 24156966
  • Sloth AD, Schmidt MR, Munk K, Kharbanda RK, Redington AN, Schmidt M, Pedersen L, Sorensen HT, Botker HE; CONDI Investigators. Improved long-term clinical outcomes in patients with ST-elevation myocardial infarction undergoing remote ischaemic conditioning as an adjunct to primary percutaneous coronary intervention. Eur Heart J. 2014 Jan;35(3):168-75. doi: 10.1093/eurheartj/eht369. Epub 2013 Sep 12.

    PubMed 24031025

Questions about this trial

What is this clinical trial studying?

A study testing Remote ischemic post-conditioning in people with Out-Of-Hospital Cardiac Arrest, run by Chonnam National University Hospital at 1 site in South Korea.

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 5 inclusion and 13 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 27 Jan 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 South Korea. 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: Overlap with other RCT). 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?

neuron specific enolase (time frame: at 48 hour after restoration of spontaneous circulation). 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 NCT03093948, which also lists 14 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 27 Jan 2021.

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