Congenital Heart DiseasePhase 1/2NCT00868101
The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery
A Phase 1/2 study testing Remote ischemic preconditioning in people with Congenital Heart Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The study research is to analyse brief episodes of limb ischemia applied to children the day before open heart surgery as protection from myocardial injury induced by extracorporeal circulation. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Dec 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1 month to 2 years age
- waiting for open heart surgery in hospital
- 2008, january to march
- Rachs-1, except the 1 category
Who cannot join
- genetic syndromes
- infected children
- immunodeficiency
- immunosuppressor use
- no parents permission
Trial locations and contacts
1 site in 1 country.
Brazil1 site
General Hospital of Ribeirao Preto, Sao Paulo University
Ribeirão Preto, São Paulo, 55
About this study
Official title: The Use of Remote Ischemic Preconditioning Applied in Child the Day Before Open Heart Surgery With Extracorporeal Circulation to Correct Congenital Heart Diseases (the Second Window Effect)
The study research is to analyse brief episodes of limb ischemia applied to children the day before open heart surgery as protection from myocardial injury induced by extracorporeal circulation.
Read the detailed description
Children undergoing repair of congenital heart defects were randomized to RIPC (remote ischemic preconditioning) or control treatment. RIPC was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff. Measurements of troponin I, brain natriuretic peptide, interleukines 8 and 10, real time PCR to NFKB and clinical parameters were obtained and compared postoperatively (4, 12, 24 and 48 hous after).
- Conditions
- Congenital Heart Disease
- Being tested
- Remote ischemic preconditioning
- Keywords
- ischemic, preconditioning, congenital heart disease
- Medical subject headings
- Heart Defects, Congenital, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningProcedure or surgery
Also called Inicial letters of the full name, Register number provided by hospital
Remote ischemic preconditioning was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff
| Study group | Role | What they receive |
|---|---|---|
| Preconditioning | Experimental | Children who received the preconditioning stimulus Receives: Procedure: Remote ischemic preconditioning |
| Control | No intervention | Children who did not receive the preconditioning stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
IkB-alpha Expression
Expressure of gene of an inhibitory protein called kappa-B alpha (IkB-alpha). Inhibits the inflammatory response protein called kappa-B nuclear factor. To measure that expression we used a real time protein chain reaction (RT-PCR), always comparing with an endogenous protein expression (this way, the encountered value is apresented in "arbitraries units", that means how much times the expression of the protein IkB-alpha is bigger than the endogenous protein that present a invariable value.
Measured: 24 hours
Interleucine 8
Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method
Measured: 24 hours
Secondary outcomes (2)
NT-proBNP
Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay.
Measured: 24 hours
Troponin I
Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startJan 2008
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcos Alves Pavione, University of Sao Paulo
- Investigators
- Ana Paula CP Carlotti, 1, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868101
- Sponsor's protocol ID
- MAP01
- Status last verified
- Dec 2011
- First submitted
- 23 Mar 2009
- Last updated
- 9 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Remote Ischemic Preconditioning Applied in Child the Day Before Open Heart Surgery With Extracorporeal Circulation to Correct Congenital Heart Diseases (the Second Window Effect)
- ClinicalTrials.gov ID
- NCT00868101
- Acronym / sponsor ID
- MAP01
- Conditions
- Congenital Heart Disease
- Keywords
- ischemic, preconditioning, congenital heart disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Posted 9 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study research is to analyse brief episodes of limb ischemia applied to children the day before open heart surgery as protection from myocardial injury induced by extracorporeal circulation.
Detailed description
Children undergoing repair of congenital heart defects were randomized to RIPC (remote ischemic preconditioning) or control treatment. RIPC was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff. Measurements of troponin I, brain natriuretic peptide, interleukines 8 and 10, real time PCR to NFKB and clinical parameters were obtained and compared postoperatively (4, 12, 24 and 48 hous after).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preconditioning | Experimental | Procedure: Remote ischemic preconditioningChildren who received the preconditioning stimulus |
| Control | No intervention | –Children who did not receive the preconditioning stimulus |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1 month to 2 years age
- waiting for open heart surgery in hospital
- 2008, january to march
- Rachs-1, except the 1 category
Key exclusion criteria (5 listed)
- genetic syndromes
- infected children
- immunodeficiency
- immunosuppressor use
- no parents permission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic preconditioningAlso: Inicial letters of the full name, Register number provided by hospitalRemote ischemic preconditioning was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff | Procedure or surgery | Preconditioning |
Primary outcome
IkB-alpha Expression
Time frame: 24 hours
Expressure of gene of an inhibitory protein called kappa-B alpha (IkB-alpha). Inhibits the inflammatory response protein called kappa-B nuclear factor. To measure that expression we used a real time protein chain reaction (RT-PCR), always comparing with an endogenous protein expression (this way, the encountered value is apresented in "arbitraries units", that means how much times the expression of the protein IkB-alpha is bigger than the endogenous protein that present a invariable value.
Interleucine 8
Time frame: 24 hours
Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method
2 secondary outcomes
NT-proBNP
Time frame: 24 hours
Troponin I
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Paula CP Carlotti, 1 study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Remote ischemic preconditioning in people with Congenital Heart Disease, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IkB-alpha Expression (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2012.