Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries

Coronary Artery Disease Clinical Trial

Official title:

Evaluation of Remote Preconditioning on Heart Resistance to Ischemia and Reperfusion Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01906918
• Other study ID #: RIPC
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2013
• Last updated: November 27, 2013
• Start date: August 2013
• Est. completion date: August 2015

Study information

• Verified date: November 2013
• Source: University of Campinas, Brazil
• Contact: Orlando Petrucci, MD, PhD
• Phone: +55 19 97253335
• Email: petrucci[@]cardiol.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Valve Diseases
• Myocardial Ischemia
• Valvular Heart Disease

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Unicamp	Campinas	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular pathway activation		2 days	No
Primary	Inflammatory response		10 days	No
Secondary	All cause of mortality		30 days	Yes
Secondary	All cause of mortality		180 days	No