Atrial FibrillationRICONCT01107184
Remote Ischemic Conditioning and Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG)
A study testing Remote ischemic conditioning in people with Atrial Fibrillation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Recent studies indicate that remote ischemic conditioning can protect the heart and other organs during cardiac surgery. The investigators aim to investigate whether such a stimulus can reduce the incidence of atrial fibrillation or other complications following coronary artery bypass surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2010to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective on-pump CABG surgery
- Informed consent
Who cannot join
- Prior cardiac surgery (Re-operations)
- Prior atrial fibrillation
- Use of class 1 or 3 anti arrhythmic medication or digoxin Use of intermittent aortic cross clamping during surgery
- Age <18 years
- Left ventricular ejection fraction ≤30%
- Serious pulmonary disease (resting pO2 <90% at room air)
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- Renal failure (clearance <30 ml/min as calculated using the Modification of Diet in Renal Disease formula)
- Liver failure
- Use of the sulfonylurea derivative glibenclamide (this drug is known to block any preconditioning stimulus
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center, University of Amsterdam
Amsterdam
About this study
Official title: A Clinical Study on the Effect of Remote Ischemic Conditioning on Atrial Fibrillation and Outcome After Coronary Artery Bypass Grafting
Recent studies indicate that remote ischemic conditioning can protect the heart and other organs during cardiac surgery. The investigators aim to investigate whether such a stimulus can reduce the incidence of atrial fibrillation or other complications following coronary artery bypass surgery.
- Conditions
- Atrial Fibrillation
- Being tested
- Remote ischemic conditioning, Sham
- Keywords
- Remote ischemic conditioning, CABG surgery, Atrial fibrillation, Coronary Artery Bypass, Ischemic Preconditioning
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
Also called Remote ischemic preconditioning, Remote ischemic postconditioning
Patients will have a automated inflator cuff placed on the upper arm during surgery. The cuff will be used to induce fore arm ischemia by inflation to 200 mmHg for 3 x 5 minutes, interspersed with 5 minutes of no-inflation and thus reperfusion.
ShamProcedure or surgery
Patients will have a automated inflator cuff placed on the upper arm during surgery which will not be inflated.
| Study group | Role | What they receive |
|---|---|---|
| Preconditioning | Experimental | The remote ischemic stimulus will be applied after induction of anaesthesia, but before cardiopulmonary bypass. Receives: Procedure: Remote ischemic conditioning |
| Postconditioning | Experimental | The remote ischemic stimulus during cardiopulmonary bypass. Receives: Procedure: Remote ischemic conditioning |
| Pre and postconditioning | Experimental | The remote ischemic stimulus will be applied twice, after induction of anaesthesia and during cardiopulmonary bypass. Receives: Procedure: Remote ischemic conditioning |
| Control | Sham comparator | Not described Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative atrial fibrillation
Measured: 72 hours
Secondary outcomes (2)
Major cardiovascular and cerebrovascular events
Major adverse events, i.e. death, acute coronary syndrome, stroke.
Measured: 3 months, 6 months, 1 year
Length of stay
Duration of hospitalization and stay on the ICU
Measured: 1 week on avarage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: slow recruitment
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 Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, B Preckel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Stef de Hert, Md, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107184
- Sponsor's protocol ID
- NL 28041.018.09
- Acronym
- RICO
- Status last verified
- Jan 2018
- First submitted
- 19 Apr 2010
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Brevoord D, Hollmann MW, De Hert SG, van Dongen EH, Heijnen BG, de Bruin A, Tolenaar N, Schlack WS, Weber NC, Dijkgraaf MG, de Groot JR, de Mol BA, Driessen AH, Momeni M, Wouters P, Bouchez S, Hofland J, Luthen C, Meijer-Treschan TA, Pannen BH, Preckel B. Effect of remote ischemic conditioning on atrial fibrillation and outcome after coronary artery bypass grafting (RICO-trial). BMC Anesthesiol. 2011 May 23;11:11. doi: 10.1186/1471-2253-11-11.
PubMed 21605453
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Effect of Remote Ischemic Conditioning on Atrial Fibrillation and Outcome After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01107184
- Acronym / sponsor ID
- RICO / NL 28041.018.09
- Conditions
- Atrial Fibrillation
- Keywords
- Remote ischemic conditioning, CABG surgery, Atrial fibrillation, Coronary Artery Bypass, Ischemic Preconditioning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 Apr 2010 (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.
Recent studies indicate that remote ischemic conditioning can protect the heart and other organs during cardiac surgery. The investigators aim to investigate whether such a stimulus can reduce the incidence of atrial fibrillation or other complications following coronary artery bypass surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preconditioning | Experimental | Procedure: Remote ischemic conditioningThe remote ischemic stimulus will be applied after induction of anaesthesia, but before cardiopulmonary bypass. |
| Postconditioning | Experimental | Procedure: Remote ischemic conditioningThe remote ischemic stimulus during cardiopulmonary bypass. |
| Pre and postconditioning | Experimental | Procedure: Remote ischemic conditioningThe remote ischemic stimulus will be applied twice, after induction of anaesthesia and during cardiopulmonary bypass. |
| Control | Sham comparator | Procedure: Sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective on-pump CABG surgery
- Informed consent
Key exclusion criteria (9 listed)
- Prior cardiac surgery (Re-operations)
- Prior atrial fibrillation
- Use of class 1 or 3 anti arrhythmic medication or digoxin Use of intermittent aortic cross clamping during surgery
- Age <18 years
- Left ventricular ejection fraction ≤30%
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 conditioningAlso: Remote ischemic preconditioning, Remote ischemic postconditioningPatients will have a automated inflator cuff placed on the upper arm during surgery. The cuff will be used to induce fore arm ischemia by inflation to 200 mmHg for 3 x 5 minutes, interspersed with 5 minutes of no-inflation and thus reperfusion. | Procedure or surgery | Postconditioning, Pre and postconditioning, Preconditioning |
| ShamPatients will have a automated inflator cuff placed on the upper arm during surgery which will not be inflated. | Procedure or surgery | Control |
Primary outcome
Post-operative atrial fibrillation
Time frame: 72 hours
2 secondary outcomes
Major cardiovascular and cerebrovascular events
Time frame: 3 months, 6 months, 1 year
Length of stay
Time frame: 1 week on avarage
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Derived from this study: PubMed 21605453Brevoord D, Hollmann MW, De Hert SG, van Dongen EH, Heijnen BG, de Bruin A, Tolenaar N, Schlack WS, Weber NC, Dijkgraaf MG, de Groot JR, de Mol BA, Driessen AH, Momeni M, Wouters P, Bouchez S, Hofland J, Luthen C, Meijer-Treschan TA, Pannen BH, Preckel B. Effect of remote ischemic conditioning on atrial fibrillation and outcome after coronary artery bypass grafting (RICO-trial). BMC Anesthesiol. 2011 May 23;11:11. doi: 10.1186/1471-2253-11-11.
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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.
Stef de Hert, Md, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Atrial Fibrillation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 9 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: stopped early, as of the sponsor's last update on 1 Feb 2018. 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 Netherlands. 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?
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
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?
Post-operative atrial fibrillation (time frame: 72 hours). 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 NCT01107184, 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 1 Feb 2018.