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

Out-Of-Hospital Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03093948
• Other study ID #: CNUH-2017-051
• Status: Terminated
• Phase: N/A
• Start date: March 21, 2017
• Est. completion date: October 21, 2019

Study information

• Verified date: January 2021
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: October 21, 2019
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• 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

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Procedure:
• Remote ischemic post-conditioning
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.

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (14)

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. do — View Citation

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 p — View Citation

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. 201 — View Citation

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. Circulati — View Citation

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 preconditioni — View Citation

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. — View Citation

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 ( — View Citation

Munk K, Andersen NH, Schmidt MR, Nielsen SS, Terkelsen CJ, Sloth E, Bøtker HE, Nielsen TT, Poulsen SH. Remote Ischemic Conditioning in Patients With Myocardial Infarction Treated With Primary Angioplasty: Impact on Left Ventricular Function Assessed by Co — View Citation

Prasad A, Gössl 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 end — View Citation

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: enhanceme — View Citation

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 L — View Citation

Sloth AD, Schmidt MR, Munk K, Kharbanda RK, Redington AN, Schmidt M, Pedersen L, Sørensen HT, Bøtker HE; CONDI Investigators. Improved long-term clinical outcomes in patients with ST-elevation myocardial infarction undergoing remote ischaemic conditioning — View Citation

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. — View Citation

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: 10.1 — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	microRNA	only in patients with shockable rhythm	at 48 hour after restoration of spontaneous circulation
Other	neurologic outcome	cerebral performance category scale 1, 2, 3, 4, 5	six month after cardiac arrest
Primary	neuron specific enolase	expressed in ng/ml	at 48 hour after restoration of spontaneous circulation
Secondary	change over troponin-I	troponin-I will be expressed in ng/ml	at 24 hour and 48 hour after restoration of spontaneous circulation
Secondary	change over creatinin kinase-MB	CK-MB will be expressed in ng/ml	at 24 hour and 48 hour after restoration of spontaneous circulation
Secondary	neurologic outcome	cerebral performance category scale 1, 2, 3, 4, 5	an average of 3 weeks after restoration of spontaneous circulation