Heart DiseasesNCT01740102
Clinical Value of Remote Ischemic Preconditioning
A study testing RIPC in people with Heart Diseases and Atrial Fibrillation, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Objectives: Despite utilization of available means for cardioprotection during cardiac surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Diseases, Atrial Fibrillation
- What is being tested?
- RIPC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2012to Sep 2013
- 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
- Elective isolated on-pump CABG surgery
- Informed consent
Who cannot join
- Patients with a severe pulmonary disease
- Patients with renal failure (GFR<30 mL/min/1.73 m2)
- Patients with liver failure
- Peripheral vascular disease affecting the upper limbs
- Patients on sulfonylurea derivatives.
- Patients with atrial fibrillation in their case history
- Prior cardiac surgery (Re-operations)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Remote Ischemic Preconditioning Reduce the Incidence of Postoperative Atrial Fibrillation in Patient Undergoing Coronary Artery Bypass Graft Surgery?
Objectives: Despite utilization of available means for cardioprotection during cardiac surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method. Laboratory research has shown promising results regarding myocardial survival during open heart surgery, but the clinical value of RIPC is still largely unknown. The investigators hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of postoperative atrial fibrillation (POAF).
- Conditions
- Heart Diseases, Atrial Fibrillation
- Being tested
- RIPC
- Keywords
- Ischemic preconditioning, Coronary artery bypass, Preoperative care, Postoperative period
- Medical subject headings
- Heart Diseases, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPCProcedure or surgery
Also called Remote ischemic preconditioning, Ischemic preconditioning
The remote ischemic preconditioning will consist of three sequential sphygmomanometer cuff inflations. The cuff will be inflated up to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle will be performed three times in total. The entire preconditioning will therefore last for 25 minutes.
| Study group | Role | What they receive |
|---|---|---|
| RIPC | Experimental | Remote ischemic preconditioning (RIPC) in the operating theatre after induction of anaesthesia and before surgery. Receives: Procedure: RIPC |
| No RIPC | No intervention | Patients in the control group will not receive remote ischemic preconditioning before the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative atrial fibrillation
A patient will be classified as belonging to the postoperative atrial fibrillation group if they have any episode of atrial fibrillation, measured by telemetry, lasting more than 1 minute during their postoperative days at the hospital.
Measured: Up to 10 days after surgery
Secondary outcomes (1)
Length of hospital stay
Measured: Maximum 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF, Namsos Hospital, Sykehuset Innlandet HF, Helse Møre og Romsdal HF
- Responsible party
- Sponsor
- Investigators
- Alexander Wahba, MD prof, Study director, Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway, and Department of Cardiothoracic Surgery, St. Olavs Hospital, Trondheim, Norway.Lars Erik B Krogstad, Principal investigator, Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740102
- Sponsor's protocol ID
- 2011/2525
- Status last verified
- Aug 2016
- First submitted
- 21 Nov 2012
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Krogstad LE, Slagsvold KH, Wahba A. Remote ischemic preconditioning and incidence of postoperative atrial fibrillation. Scand Cardiovasc J. 2015 Jun;49(3):117-22. doi: 10.3109/14017431.2015.1010565. Epub 2015 Feb 24.
PubMed 25613907
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Remote Ischemic Preconditioning Reduce the Incidence of Postoperative Atrial Fibrillation in Patient Undergoing Coronary Artery Bypass Graft Surgery?
- ClinicalTrials.gov ID
- NCT01740102
- Acronym / sponsor ID
- 2011/2525
- Conditions
- Heart Diseases, Atrial Fibrillation
- Keywords
- Ischemic preconditioning, Coronary artery bypass, Preoperative care, Postoperative period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF, Namsos Hospital, Sykehuset Innlandet HF, Helse Møre og Romsdal HF
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Dec 2012 (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.
Objectives: Despite utilization of available means for cardioprotection during cardiac surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method. Laboratory research has shown promising results regarding myocardial survival during open heart surgery, but the clinical value of RIPC is still largely unknown. The investigators hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of postoperative atrial fibrillation (POAF).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC | Experimental | Procedure: RIPCRemote ischemic preconditioning (RIPC) in the operating theatre after induction of anaesthesia and before surgery. |
| No RIPC | No intervention | –Patients in the control group will not receive remote ischemic preconditioning before the surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective isolated on-pump CABG surgery
- Informed consent
Key exclusion criteria (7 listed)
- Patients with a severe pulmonary disease
- Patients with renal failure (GFR<30 mL/min/1.73 m2)
- Patients with liver failure
- Peripheral vascular disease affecting the upper limbs
- Patients on sulfonylurea derivatives.
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 |
|---|---|---|
| RIPCAlso: Remote ischemic preconditioning, Ischemic preconditioningThe remote ischemic preconditioning will consist of three sequential sphygmomanometer cuff inflations. The cuff will be inflated up to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle will be performed three times in total. The entire preconditioning will therefore last for 25 minutes. | Procedure or surgery | RIPC |
Primary outcome
Postoperative atrial fibrillation
Time frame: Up to 10 days after surgery
A patient will be classified as belonging to the postoperative atrial fibrillation group if they have any episode of atrial fibrillation, measured by telemetry, lasting more than 1 minute during their postoperative days at the hospital.
1 secondary outcome
Length of hospital stay
Time frame: Maximum 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Results publication: PubMed 25613907Krogstad LE, Slagsvold KH, Wahba A. Remote ischemic preconditioning and incidence of postoperative atrial fibrillation. Scand Cardiovasc J. 2015 Jun;49(3):117-22. doi: 10.3109/14017431.2015.1010565. Epub 2015 Feb 24.
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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.
Alexander Wahba, MD prof study director
Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway, and Department of Cardiothoracic Surgery, St. Olavs Hospital, Trondheim, Norway.
Lars Erik B Krogstad principal investigator
Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIPC in people with Heart Diseases and Atrial Fibrillation, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 inclusion and 7 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 4 Aug 2016. 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 Norway. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative atrial fibrillation (time frame: Up to 10 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01740102, which also lists 1 linked publication.
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 4 Aug 2016; AzTrials last refreshed its copy on 30 Oct 2026.