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Impact of remote ischemic preconditioning preceding coronary artery bypass grafting on inducing neuroprotection (RIPCAGE): study protocol for a randomized controlled trial.
Trials 2014; 15:414T

Abstract

BACKGROUND

Neurological complications after cardiac surgery have a profound impact on postoperative survival and quality of life. The increasing importance of strategies designed to improve neurological outcomes mirrors the growing risk burden of the contemporary cardiac surgical population. Remote ischemic preconditioning (RIPC) reduces adverse sequelae of ischemia in vulnerable organs by subjecting tissues with high ischemic tolerance to brief periods of hypoperfusion. This trial will evaluate the neuroprotective effect of RIPC in the cardiac surgical arena, by employing magnetic resonance imaging (MRI) and neurocognitive testing.

METHODS

Patients scheduled for elective coronary artery bypass grafting with the use of cardiopulmonary bypass will be screened for the study. Eligible patients will be randomized to undergo either a validated RIPC protocol or a sham procedure. The RIPC will be induced by inflation of a blood pressure cuff to 200 mmHg for 5 minutes, followed by a 5-minute reperfusion period. Three sequences of interchanging cuff inflations and deflations will be employed. Neurocognitive testing and MRI imaging will be performed preoperatively and on postoperative day 7. Paired pre- and postoperative neurocognitive and neuroimaging data will then be compared. The primary composite outcome measure will consist of new ischemic lesions on brain MRI, postprocedural impairment in brain connectivity on resting-state functional MRI (rs-fMRI), and significant new declines in neurocognitive performance. The secondary endpoint measures will be the individual components of the primary endpoint measures, expressed as continuous variables, troponin T release on postoperative day 1 and the incidence of major adverse cardiovascular events at 3 months postoperatively. Major adverse cardiovascular events, including accumulating cardiovascular mortality, stroke, nonfatal myocardial infarction, and rehospitalization for ischemia, will form a composite endpoint measure.

DISCUSSION

This trial will aim to assess whether RIPC in patients subjected to surgical myocardial revascularization employing cardiopulmonary bypass initiates a neuroprotective response. Should the results of this trial indicate that RIPC is effective in reducing the incidence of adverse neurological events in patients undergoing coronary artery bypass grafting, it could impact on the current standard of care.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02177981.

Authors+Show Affiliations

Department of Cardiac Surgery, University Hospital Center Zagreb, University of Zagreb, Kispaticeva 12, 10 000 Zagreb, Croatia. hgasparovic@gmail.com.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25348157

Citation

Gasparovic, Hrvoje, et al. "Impact of Remote Ischemic Preconditioning Preceding Coronary Artery Bypass Grafting On Inducing Neuroprotection (RIPCAGE): Study Protocol for a Randomized Controlled Trial." Trials, vol. 15, 2014, p. 414.
Gasparovic H, Kopjar T, Rados M, et al. Impact of remote ischemic preconditioning preceding coronary artery bypass grafting on inducing neuroprotection (RIPCAGE): study protocol for a randomized controlled trial. Trials. 2014;15:414.
Gasparovic, H., Kopjar, T., Rados, M., Anticevic, A., Rados, M., Malojcic, B., ... Biocina, B. (2014). Impact of remote ischemic preconditioning preceding coronary artery bypass grafting on inducing neuroprotection (RIPCAGE): study protocol for a randomized controlled trial. Trials, 15, p. 414. doi:10.1186/1745-6215-15-414.
Gasparovic H, et al. Impact of Remote Ischemic Preconditioning Preceding Coronary Artery Bypass Grafting On Inducing Neuroprotection (RIPCAGE): Study Protocol for a Randomized Controlled Trial. Trials. 2014 Oct 27;15:414. PubMed PMID: 25348157.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of remote ischemic preconditioning preceding coronary artery bypass grafting on inducing neuroprotection (RIPCAGE): study protocol for a randomized controlled trial. AU - Gasparovic,Hrvoje, AU - Kopjar,Tomislav, AU - Rados,Milan, AU - Anticevic,Alan, AU - Rados,Marko, AU - Malojcic,Branko, AU - Ivancan,Visnja, AU - Fabijanic,Tea, AU - Cikes,Maja, AU - Milicic,Davor, AU - Gasparovic,Vladimir, AU - Biocina,Bojan, Y1 - 2014/10/27/ PY - 2014/07/18/received PY - 2014/10/15/accepted PY - 2014/10/29/entrez PY - 2014/10/29/pubmed PY - 2015/7/15/medline SP - 414 EP - 414 JF - Trials JO - Trials VL - 15 N2 - BACKGROUND: Neurological complications after cardiac surgery have a profound impact on postoperative survival and quality of life. The increasing importance of strategies designed to improve neurological outcomes mirrors the growing risk burden of the contemporary cardiac surgical population. Remote ischemic preconditioning (RIPC) reduces adverse sequelae of ischemia in vulnerable organs by subjecting tissues with high ischemic tolerance to brief periods of hypoperfusion. This trial will evaluate the neuroprotective effect of RIPC in the cardiac surgical arena, by employing magnetic resonance imaging (MRI) and neurocognitive testing. METHODS: Patients scheduled for elective coronary artery bypass grafting with the use of cardiopulmonary bypass will be screened for the study. Eligible patients will be randomized to undergo either a validated RIPC protocol or a sham procedure. The RIPC will be induced by inflation of a blood pressure cuff to 200 mmHg for 5 minutes, followed by a 5-minute reperfusion period. Three sequences of interchanging cuff inflations and deflations will be employed. Neurocognitive testing and MRI imaging will be performed preoperatively and on postoperative day 7. Paired pre- and postoperative neurocognitive and neuroimaging data will then be compared. The primary composite outcome measure will consist of new ischemic lesions on brain MRI, postprocedural impairment in brain connectivity on resting-state functional MRI (rs-fMRI), and significant new declines in neurocognitive performance. The secondary endpoint measures will be the individual components of the primary endpoint measures, expressed as continuous variables, troponin T release on postoperative day 1 and the incidence of major adverse cardiovascular events at 3 months postoperatively. Major adverse cardiovascular events, including accumulating cardiovascular mortality, stroke, nonfatal myocardial infarction, and rehospitalization for ischemia, will form a composite endpoint measure. DISCUSSION: This trial will aim to assess whether RIPC in patients subjected to surgical myocardial revascularization employing cardiopulmonary bypass initiates a neuroprotective response. Should the results of this trial indicate that RIPC is effective in reducing the incidence of adverse neurological events in patients undergoing coronary artery bypass grafting, it could impact on the current standard of care. TRIAL REGISTRATION: ClinicalTrials.gov NCT02177981. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/25348157/Impact_of_remote_ischemic_preconditioning_preceding_coronary_artery_bypass_grafting_on_inducing_neuroprotection__RIPCAGE_:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15-414 DB - PRIME DP - Unbound Medicine ER -