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Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Orlando Petrucci, University of Campinas, Brazil.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Orlando Petrucci, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01906918
First received: July 21, 2013
Last updated: November 27, 2013
Last verified: November 2013
  Purpose
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.

Condition Intervention
Coronary Artery Disease Valvular Heart Disease Procedure: IRPC, Remote preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Evaluation of Remote Preconditioning on Heart Resistance to Ischemia and Reperfusion Injury

Further study details as provided by Orlando Petrucci, University of Campinas, Brazil:

Primary Outcome Measures:
  • Molecular pathway activation [ Time Frame: 2 days ]
  • Inflammatory response [ Time Frame: 10 days ]

Secondary Outcome Measures:
  • All cause of mortality [ Time Frame: 30 days ]
  • All cause of mortality [ Time Frame: 180 days ]

Estimated Enrollment: 120
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IRPC, Remote preconditioning
This group will be submitted to ischemic preconditioning
Procedure: IRPC, Remote preconditioning
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.
Placebo Comparator: Control
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01906918

Contacts
Contact: Orlando Petrucci, MD, PhD +55 19 97253335 petrucci@cardiol.br

Locations
Brazil
Hospital das Clínicas da Unicamp Recruiting
Campinas, Sao Paulo, Brazil, 13100000
Contact: Fany Lima    ++55 (19) 3521-7131    fanyslima@gmail.com   
Principal Investigator: Orlando Petrucci, MD, PhD         
Sub-Investigator: Fany Lima, RN         
Sub-Investigator: Pedro Paulo M Oliveira, MD, PhD         
Sub-Investigator: Lindemberg M Silveira-Filho, MD, PhD         
Sub-Investigator: Karlos AS Vilarinho, MD, PhD         
Sub-Investigator: Elaine S Severino, MD, PhD         
Sub-Investigator: Daniela D Carvalho, PhD         
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Study Chair: Orlando Petrucci, MD, PhD University of Campinas
Principal Investigator: Fany Lima, RN University of Campinas
  More Information

Responsible Party: Orlando Petrucci, Phd, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01906918     History of Changes
Other Study ID Numbers: RIPC
Study First Received: July 21, 2013
Last Updated: November 27, 2013

Keywords provided by Orlando Petrucci, University of Campinas, Brazil:
ischemia
reperfusion
myocardial ischemia
myocardial reperfusion

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 23, 2017