Status unknownNCT01906918Updated Nov 28, 2013

Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries

An interventional study of IRPC, Remote preconditioning in Coronary Artery Disease and Valvular Heart Disease, sponsored by University of Campinas, Brazil. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-11-28.

Sponsored by University of Campinas, Brazil · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2013), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 120
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Coronary Artery Disease
Valvular Heart Disease

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Keywords

ischemia
reperfusion
myocardial ischemia
myocardial reperfusion

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 120 is close to the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

University of Campinas, Brazil is the lead sponsor of 166 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Care provider)
Enrollment: 120 participants (estimated)

Study arms

Experimental
IRPC, Remote preconditioning
This group will be submitted to ischemic preconditioning
Procedure: IRPC, Remote preconditioning
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.

Interventions

ProcedureIRPC, 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.

What researchers measure

Primary outcomes

Molecular pathway activation
Time frame: 2 days
Inflammatory response
Time frame: 10 days

Secondary outcomes

All cause of mortality
Time frame: 30 days
All cause of mortality
Time frame: 180 days

Study locations

1 of 1 sites recruiting

Hospital das Clínicas da Unicamp
Campinas, Sao Paulo 13100000, Brazil
- Fany Lima · Contact · fanyslima@gmail.com · ++55 (19) 3521-7131
- Orlando Petrucci, MD, PhD · Principal 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 · Sub investigator
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01906918
Lead sponsor: University of Campinas, Brazil
Responsible party: Orlando Petrucci (Phd, University of Campinas, Brazil) — Principal investigator
First posted: Jul 24, 2013
Start date: Aug 2013
Primary completion: Aug 2015 (estimated)
Completion: Aug 2015 (estimated)
Last update: Nov 28, 2013

Study contacts

Orlando Petrucci, MD, PhD

Contact

petrucci@cardiol.br

+55 19 97253335

Orlando Petrucci, MD, PhD

study chair · University of Campinas

Fany Lima, RN

principal investigator · University of Campinas

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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