NCT03340181

Brief Summary

The purpose of the study was to verify the myocardial protective effect of RIPC in patients undergoing OPCABG.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

1.4 years

First QC Date

October 31, 2017

Last Update Submit

November 8, 2017

Conditions

OPCABG

Keywords

RIPC, myocardial protective effect

Outcome Measures

Primary Outcomes (1)

  • ICU staying time

    the time patients spend in ICU after surgery

    average of 1 year

Study Arms (2)

RIPC

EXPERIMENTAL

4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmHg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb.

Other: RIPC

control

SHAM COMPARATOR

patient in control group using a blood pressure cuff on an upper limb without inflating

Other: RIPC

Interventions

RIPCOTHER

4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmHg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb before skin incision.

RIPCcontrol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • serious changes in several coronary arteries that need to receive OPCABG
  • NHYA II-III
  • ASA II-III

You may not qualify if:

  • LVEF\< 35%
  • acute myocardial infarction
  • multiple organ dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huilin Wang

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

Study Officials

  • Hui-lin Wang, Phd

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-fang Guo, Phd

CONTACT

021-64041990guo.kefang@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 13, 2017

Study Start

November 1, 2017

Primary Completion

March 31, 2019

Study Completion

June 30, 2019

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

CN(1)