Coronary Artery DiseaseNCT01906918
Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries
A study testing IRPC, Remote preconditioning in people with Coronary Artery Disease and Valvular Heart Disease, run by University of Campinas, Brazil at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Valvular Heart Disease
- What is being tested?
- IRPC, Remote preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da Unicamp
Campinas, São Paulo, 13100000
Fany Lima, ++55 (19) 3521-7131, fanyslima@gmail.com
Orlando Petrucci, MD, PhD
About this study
Official title: Evaluation of Remote Preconditioning on Heart Resistance to Ischemia and Reperfusion Injury
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
- Coronary Artery Disease, Valvular Heart Disease
- Being tested
- IRPC, Remote preconditioning
- Keywords
- ischemia, reperfusion, myocardial ischemia, myocardial reperfusion
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases, Ischemia, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRPC, Remote preconditioningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| IRPC, Remote preconditioning | Experimental | This group will be submitted to ischemic preconditioning Receives: Procedure: IRPC, Remote preconditioning |
| Control | Placebo comparator | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular pathway activation
Measured: 2 days
Inflammatory response
Measured: 10 days
Secondary outcomes (2)
All cause of mortality
Measured: 30 days
All cause of mortality
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orlando Petrucci, University of Campinas, Brazil
- Investigators
- Orlando Petrucci, MD, PhD, Study chair, University of CampinasFany Lima, RN, Principal investigator, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906918
- Sponsor's protocol ID
- RIPC
- Status last verified
- Nov 2013
- First submitted
- 21 Jul 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Remote Preconditioning on Heart Resistance to Ischemia and Reperfusion Injury
- ClinicalTrials.gov ID
- NCT01906918
- Acronym / sponsor ID
- RIPC
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Keywords
- ischemia, reperfusion, myocardial ischemia, myocardial reperfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRPC, Remote preconditioning | Experimental | Procedure: IRPC, Remote preconditioningThis group will be submitted to ischemic preconditioning |
| Control | Placebo comparator | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (8 listed)
- 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 ˃)
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 |
|---|---|---|
| IRPC, Remote preconditioningThe 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. | Procedure or surgery | IRPC, Remote preconditioning |
Primary outcome
Molecular pathway activation
Time frame: 2 days
Inflammatory response
Time frame: 10 days
2 secondary outcomes
All cause of mortality
Time frame: 30 days
All cause of mortality
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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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.
Orlando Petrucci, MD, PhD study chair
University of Campinas
Fany Lima, RN principal investigator
University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRPC, Remote preconditioning in people with Coronary Artery Disease and Valvular Heart Disease, run by University of Campinas, Brazil 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 8 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: status not confirmed, as of the sponsor's last update on 28 Nov 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orlando Petrucci, MD, PhD (+55 19 97253335, petrucci@cardiol.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular pathway activation (time frame: 2 days). 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 28 Nov 2013.