Remote Ischemic Preconditioning With Postconditioning in... | NCT02149316

Studies
Remote Ischemic Preconditioning With Postconditioning in Heart Transplantation Surgery

NCT02149316

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Completed

Last Update Posted

Dec 23, 2016Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Myocardial Ischemic Reperfusion Injury
End Stage Heart Disease
Heart Failure
Cardiomyopathy

Interventions

RIPC+RIPostC
control

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

May 26, 2014

First Submission Date that Met QC Criteria

May 26, 2014

First Posted Date

May 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2016

Last Update Posted Date

Dec 23, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guyan Wang, The Chief of Infection-Control Department, Chinese Academy of Medical Sciences, Fuwai HospitalPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether remote ischemic preconditioning with postconditioning (RIPC+RIPostC) reduces myocardial injury and improves clinical outcomes in heart transplantation surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RIPC+RIPostC	Experimental		Procedure: RIPC+RIPostC
control	Sham Comparator		Procedure: control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RIPC+RIPostC	Procedure	Four 5 min cycles of upper limb ischemia and reperfusion by a cuff inflated to 200 mmHg, twice (after anesthesia induction and before surgery started, at 20min after aortic declamping)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum cardiac troponin I (cTnI)		within 72 hours after aortic declamping

Secondary Outcomes

Measure	Description	Time Frame
plasma microRNA-133b (miR-133b)		within 72 hours after aortic declamping
plasma microRNA-208a (miR-208a)		within 72 hours after aortic declamping

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

scheduled for elective orthotopic heart transplantation surgery

Exclusion Criteria:

peripheral vascular disease affecting the upper arms
mechanical circulatory support before surgery
taking the antidiabetic sulphonylurea, glibenclamide
cold ischemic time of donor heart > 12 hours
repeated heart surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guyan Wang, PhD	State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC, Beijing, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC		Beijing		100037	China

Condition Browse Module

MeSH Terms

ID	Term
D015428	Myocardial Reperfusion Injury
D006333	Heart Failure
D009202	Cardiomyopathies

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D017202	Myocardial Ischemia
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided