NCT02729155

Brief Summary

This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning for prevention of contrast-induced acute kidney injury in patient undergoing coronary angiography and angioplasty

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
596

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

4.6 years

First QC Date

March 31, 2016

Last Update Submit

August 28, 2018

Conditions

Ischemic Reperfusion Injury

Keywords

Ischemic PreconditioningPostconditioningAngioplastyAngiographyContrast-Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value

    Within a period of 24 hours after contrast medium administration

Secondary Outcomes (7)

  • Change in sCr and eGFR from baseline

    Within a period of 24 hours after contrast medium administration

  • Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group

    Within a period of 6 months after contrast medium administration

  • Incidence(%) of CI-AKI in differrent subgroups of patient characteristics

    Within a period of 24 hours after contrast medium administration

  • Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost

    Within a period of 24 hours after contrast medium administration

  • Incidence(%) of MACCE in differrent subgroups of patient characteristics

    Within a period of 6 months after contrast medium administration

  • +2 more secondary outcomes

Study Arms (4)

RIPre + RIPost

EXPERIMENTAL

Intervention: RIPre 200 mmHg + RIPost 200 mmHg

Procedure: RIPreProcedure: RIPost

RIPre + Sham

EXPERIMENTAL

Intervention: RIPre 200 mmHg + Sham 10 mmHg

Procedure: RIPreProcedure: Sham-Post

Sham + RIPost

EXPERIMENTAL

Intervention: Sham 10 mmHg + RIPost 200 mmHg

Procedure: RIPostProcedure: Sham-Pre

Sham + Sham

SHAM COMPARATOR

Intervention: Sham 10 mmHg + Sham 10 mmHg

Procedure: Sham-PreProcedure: Sham-Post

Interventions

RIPrePROCEDURE

Preconditioning 200 mmHg x 5 minutes before procedure

RIPre + RIPostRIPre + Sham
RIPostPROCEDURE

Postconditioning 200 mmHg x 5 minutes after procedure

RIPre + RIPostSham + RIPost
Sham-PrePROCEDURE

Sham 10 mmHg x 5 minutes before procedure

Sham + RIPostSham + Sham
Sham-PostPROCEDURE

Sham 10 mmHg x 5 minutes after procedure

RIPre + ShamSham + Sham

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The patient have indication for coronary angiography or angioplasty.
  • Impaired renal function with reduced eGFR \< 60 ml/min/1.73 m2 by CKD-EPI equation.
  • Written informed consent.

You may not qualify if:

  • History of contrast allergy.
  • The patient had end-stage renal failure with the need for hemodialysis.
  • The patient take medications that affect the kidneys function within 48 hours before study.
  • The patient had acute kidney injury from any cause.
  • The patient was received contrast media within 2 weeks before study.
  • The patient had cardiac arrest or shock.
  • The patient had peripheral arterial disease (PAD)
  • Pregnancy
  • Refused to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine

Bangkok, 10400, Thailand

RECRUITING

Study Officials

  • Nakarin Sansanayudh, MD,PhD

    Phramongkutklao College of Medicine and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nakarin Sansanayudh, MD,PhD

CONTACT

+6627639300dr_nakarin@hotmail.com

Pawit Pipatwattanakul, MD

CONTACT

+6613728821pa_wit@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phramongkutklao College of Medicine and Hospital

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 6, 2016

Study Start

October 1, 2015

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

Locations

TH(1)