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Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries

Primary Purpose

Coronary Artery Disease, Valvular Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
IRPC, Remote preconditioning
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring ischemia, reperfusion, myocardial ischemia, myocardial reperfusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients older than 18 years
  • Scheduled for coronary artery bypass grafting with or without valve replacement associated
  • Use of blood cardioplegia
  • EuroSCORE II greater than or equal to 1.0%

Exclusion Criteria:

  • History of cardiogenic shock
  • Complications in the admission
  • Pregnant patients
  • Severe peripheral arterial disease affecting the upper limbs
  • Liver failure (bilirubin ˃ 20 mmol / L, INR 2.0 ˃)
  • Significant pulmonary disease (˂ FEV1 40%)
  • Renal failure with glomerular filtration rate ˂ ml/min/1,73 m²
  • Concomitant treatment with glibenclamide or nicorandil (medications that interfere with cardioprotection induced by IPCR)

Sites / Locations

  • Hospital das Clínicas da UnicampRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IRPC, Remote preconditioning

Control

Arm Description

This group will be submitted to ischemic preconditioning

This patients will be submitted to the standard surgery protocol in the institution. The patients will not be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion.

Outcomes

Primary Outcome Measures

Molecular pathway activation
Inflammatory response

Secondary Outcome Measures

All cause of mortality
All cause of mortality

Full Information

First Posted
July 21, 2013
Last Updated
November 27, 2013
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01906918
Brief Title
Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries
Official Title
Evaluation of Remote Preconditioning on Heart Resistance to Ischemia and Reperfusion Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Strategies for myocardial protection during open heart surgeries are desired. Several experimental studies have shown beneficial effects of remote ischemic preconditioning (RIPC). The underlying mechanisms are not totally understood. This study intends to evaluate molecular mechanisms involved with RIPC on myocardium of patients underwent open heart surgeries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Valvular Heart Disease
Keywords
ischemia, reperfusion, myocardial ischemia, myocardial reperfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IRPC, Remote preconditioning
Arm Type
Experimental
Arm Description
This group will be submitted to ischemic preconditioning
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This patients will be submitted to the standard surgery protocol in the institution. The patients will not be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion.
Intervention Type
Procedure
Intervention Name(s)
IRPC, Remote preconditioning
Intervention Description
The patients will be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion. This cycle will be repeated 4 times.
Primary Outcome Measure Information:
Title
Molecular pathway activation
Time Frame
2 days
Title
Inflammatory response
Time Frame
10 days
Secondary Outcome Measure Information:
Title
All cause of mortality
Time Frame
30 days
Title
All cause of mortality
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years Scheduled for coronary artery bypass grafting with or without valve replacement associated Use of blood cardioplegia EuroSCORE II greater than or equal to 1.0% Exclusion Criteria: History of cardiogenic shock Complications in the admission Pregnant patients Severe peripheral arterial disease affecting the upper limbs Liver failure (bilirubin ˃ 20 mmol / L, INR 2.0 ˃) Significant pulmonary disease (˂ FEV1 40%) Renal failure with glomerular filtration rate ˂ ml/min/1,73 m² Concomitant treatment with glibenclamide or nicorandil (medications that interfere with cardioprotection induced by IPCR)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Orlando Petrucci, MD, PhD
Phone
+55 19 97253335
Email
petrucci@cardiol.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orlando Petrucci, MD, PhD
Organizational Affiliation
University of Campinas
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fany Lima, RN
Organizational Affiliation
University of Campinas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas da Unicamp
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13100000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fany Lima
Phone
++55 (19) 3521-7131
Email
fanyslima@gmail.com
First Name & Middle Initial & Last Name & Degree
Orlando Petrucci, MD, PhD
First Name & Middle Initial & Last Name & Degree
Fany Lima, RN
First Name & Middle Initial & Last Name & Degree
Pedro Paulo M Oliveira, MD, PhD
First Name & Middle Initial & Last Name & Degree
Lindemberg M Silveira-Filho, MD, PhD
First Name & Middle Initial & Last Name & Degree
Karlos AS Vilarinho, MD, PhD
First Name & Middle Initial & Last Name & Degree
Elaine S Severino, MD, PhD
First Name & Middle Initial & Last Name & Degree
Daniela D Carvalho, PhD

12. IPD Sharing Statement

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Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries

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