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Single-cycle Remote Ischemic Preconditioning and Postconditioning for Prevention of Contrast-Induced Nephropathy

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ClinicalTrials.gov Identifier: NCT02729155
Recruitment Status : Unknown
Verified August 2018 by Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital.
Recruitment status was:  Recruiting
First Posted : April 6, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Ischemic Reperfusion Injury Procedure: RIPre Procedure: RIPost Procedure: Sham-Pre Procedure: Sham-Post Not Applicable

Detailed Description:
randomized controlled trial
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 596 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Single-cycle Remote Ischemic Pre/Post-conditioning, for Prevention of Contrast-induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Coronary Angiography or Coronary Angioplasty
Study Start Date : October 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arms and Interventions
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Arm Intervention/treatment
Experimental: RIPre + RIPost
Intervention: RIPre 200 mmHg + RIPost 200 mmHg
 Procedure: RIPre
Preconditioning 200 mmHg x 5 minutes before procedure

Procedure: RIPost
Postconditioning 200 mmHg x 5 minutes after procedure
Experimental: RIPre + Sham
Intervention: RIPre 200 mmHg + Sham 10 mmHg
 Procedure: RIPre
Preconditioning 200 mmHg x 5 minutes before procedure

Procedure: Sham-Post
Sham 10 mmHg x 5 minutes after procedure
Experimental: Sham + RIPost
Intervention: Sham 10 mmHg + RIPost 200 mmHg
 Procedure: RIPost
Postconditioning 200 mmHg x 5 minutes after procedure

Procedure: Sham-Pre
Sham 10 mmHg x 5 minutes before procedure
Sham Comparator: Sham + Sham
Intervention: Sham 10 mmHg + Sham 10 mmHg
 Procedure: Sham-Pre
Sham 10 mmHg x 5 minutes before procedure

Procedure: Sham-Post
Sham 10 mmHg x 5 minutes after procedure


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: Within a period of 24 hours after contrast medium administration ]

Secondary Outcome Measures :
  1. Change in sCr and eGFR from baseline [ Time Frame: Within a period of 24 hours after contrast medium administration ]
  2. Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group [ Time Frame: Within a period of 6 months after contrast medium administration ]
    MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack

  3. Incidence(%) of CI-AKI in differrent subgroups of patient characteristics [ Time Frame: Within a period of 24 hours after contrast medium administration ]

    Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM.

    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.


  4. Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost [ Time Frame: Within a period of 24 hours after contrast medium administration ]
    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

  5. Incidence(%) of MACCE in differrent subgroups of patient characteristics [ Time Frame: Within a period of 6 months after contrast medium administration ]

    Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM.

    MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack


  6. Incidence(%) of MACCE in patients with vs without RIPre and RIPost [ Time Frame: Within a period of 6 months after contrast medium administration ]

    Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM.

    MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack


  7. Incidence(%) of MACCE in patients who have CI-AKI vs patients who have no CI-AKI [ Time Frame: Within a period of 6 months after contrast medium administration ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729155


Contacts
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Contact: Nakarin Sansanayudh, MD,PhD +6627639300 ext 93807 dr_nakarin@hotmail.com
Contact: Pawit Pipatwattanakul, MD +6613728821 pa_wit@hotmail.com

Locations
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Thailand
Department of Internal Medicine Recruiting
Bangkok, Thailand, 10400
Contact: Nakarin Sansanayudh, MD,PhD    +6623547600 ext 93827    dr_nakarin@hotmail.com   
Contact: Pawit Pipatwattanakul, MD    +6613728821    pa_wit@hotmail.com   
Sponsors and Collaborators
Phramongkutklao College of Medicine and Hospital
Investigators
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Principal Investigator: Nakarin Sansanayudh, MD,PhD Phramongkutklao College of Medicine and Hospital
More Information
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Responsible Party: Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital
ClinicalTrials.gov Identifier: NCT02729155    
Other Study ID Numbers: PMK-SCRIP-CIN
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital:
Ischemic Preconditioning
Postconditioning
Angioplasty
Angiography
Contrast-Induced Nephropathy
Additional relevant MeSH terms:
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Reperfusion Injury
Ischemia
Pathologic Processes
 Vascular Diseases
Cardiovascular Diseases
Postoperative Complications