NCT01946087

Brief Summary

The aim of this study is to investigate whether RIPC protects the heart against ischemia reperfusion injury on the concentrically hypertrophied myocardium

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

September 4, 2013

Last Update Submit

November 19, 2016

Conditions

Patients With Elective Aortic Valve Replacement

Keywords

Remote ischemic preconditioningcardiac surgeryleft ventricular hypertrophyreperfusion injury salvage kinase

Outcome Measures

Primary Outcomes (3)

  • Serum levels of CK-MB and Tn-T

    baseline

  • Serum levels of CK-MB and Tn-T

    12-hour after surgery

  • Serum levels of CK-MB and Tn-T

    24-hour after surgery

Secondary Outcomes (2)

  • Myocardial activation of protective signaling pathway

    Before commencement of CPB

  • Myocardial activation of protective signaling pathway

    After taking off CPB

Study Arms (2)

RIPC group

EXPERIMENTAL
Procedure: Remote ischemic preconditioning at left upper arm

Control group

PLACEBO COMPARATOR
Procedure: Control group

Interventions

Remote ischemic preconditioning at left upper armPROCEDURE

Placement of automated cuff-inflator on the left upper arm after induction of anesthesia RIPCgroup-3 cycles of 5 min ischemia (300 mmHg inflation) \& 5 min reperfusion (deflation)

RIPC group
Control groupPROCEDURE

keeping the cuff deflated

Control group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥20 years with severe degenerative AS presenting concentric remodeling of the LV, who were scheduled for AVR

You may not qualify if:

  • diabetes mellitus,
  • coronary stenosis ≥70%,
  • renal failure (serum creatinine \> 2.0 mg/dL),
  • upper arm peripheral vascular disease,
  • LV ejection fraction \<50%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Hypertrophy, Left Ventricular

Interventions

Control Groups

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 19, 2013

Study Start

June 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations

KR(1)