The Neuroprotection of Remote Ischemic Preconditioning (RIPC) on Cardiac Surgery in Multicenter
1 other identifier
interventional
150
1 country
1
Brief Summary
The current study is designed to clarify the neuroprotective effect of remote ischemic preconditioning on the patients underwent open-heart cardiac surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 15, 2010
CompletedFirst Posted
Study publicly available on registry
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedAugust 21, 2012
June 1, 2009
4 years
September 15, 2010
August 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the neurological injury markers, including serum level of S-100B and NSE
the biomarkers of brain injury
before surgery, 6h, 24h, 48h, and 72h after bypass
Secondary Outcomes (1)
mini-mental state examination scale
6 months after surgery
Study Arms (2)
sham RIPC
SHAM COMPARATORPatients had a deflated cuff placed on the right upper arm for 30 min.
RIPC treatment
EXPERIMENTALRIPC consisted of three 5-min cycles of right upper arm ischemia, which was induced by an automated cuff-inflator placed on the right upper arm and inflated to 200 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated
Interventions
RIPC consisted of three 5-min cycles of right upper arm ischemia, which was induced by an automated cuff-inflator placed on the right upper arm and inflated to 200 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated
Patients had a deflated cuff placed on the right upper arm for 30 min without any inflation procedure.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with acquired heart valve diseases scheduled for valve replacement or CABG
You may not qualify if:
- Were unable to give informed consent
- Patients who presented with other systemic diseases such as hepatic,renal, and pulmonary diseases, or have had a heart operation before, were excluded.
- Additionally, patients taking antidiabetic sulfonylurea or glibenclamide were excluded because these agents have been shown to abrogate the cardioprotection elicited by ischemic preconditioning.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital
Xi'an, Shaanxi, 710032, China
Related Publications (1)
Zhu S, Zheng Z, Lv W, Ouyang P, Han J, Zhang J, Dong H, Lei C. Neuroprotective effect of remote ischemic preconditioning in patients undergoing cardiac surgery: A randomized controlled trial. Front Cardiovasc Med. 2022 Sep 6;9:952033. doi: 10.3389/fcvm.2022.952033. eCollection 2022.
PMID: 36148077DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hailong Dong, MD,PhD
Xijing Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2010
First Posted
November 1, 2010
Study Start
June 1, 2009
Primary Completion
June 1, 2013
Study Completion
August 1, 2013
Last Updated
August 21, 2012
Record last verified: 2009-06