Atrial FibrillationPhase 1NCT00882622
Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery
A Phase 1 study testing Remote Ischemic Preconditioning in people with Atrial Fibrillation and Ventricular Arrythmias, run by Patrick Meybohm at 2 sites in Germany.
Trial summary
The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cardiac function in patients undergoing cardiac surgery compared to control intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Ventricular Arrythmias, Myocardial Injury
- What is being tested?
- Remote Ischemic Preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2009to Feb 2009
- Phase
- Phase 1
- 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
- Patient undergoing heart surgery on cardiopulmonary bypass
Who cannot join
- Emergency cases
- Myocardial infarction up to 7 days prior to enrollment
- Ejection fraction less than 30%
- Inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital
Frankfurt am Main
University Hospital Schleswig-Holstein
Kiel, 24105
About this study
The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cardiac function in patients undergoing cardiac surgery compared to control intervention.
Read the detailed description
In detail, we will focus on new onset of atrial fibrillation, ventricular arrhythmias, myocardial injury, and cardiac function. Furthermore, we aim to investigate underlying pathways of RIPC in modifying the perioperative stress response.
- Being tested
- Remote Ischemic Preconditioning, Control/sham procedure
- Keywords
- Ischemic Preconditioning, Cardiac Surgery
- 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 PreconditioningProcedure or surgery
RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 15 mm Hg greater than the systolic arterial pressure measured via the arterial line.
Control/sham procedureProcedure or surgery
Sham placement of the blood pressure cuff around the upper limb without inflation.
| Study group | Role | What they receive |
|---|---|---|
| RIPC | Active comparator | Not described Receives: Procedure: Remote Ischemic Preconditioning |
| CONTROL | Sham comparator | Not described Receives: Procedure: Control/sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
New onset of atrial fibrillation
Measured: Within 30 days after surgery
Secondary outcomes (1)
Ventricular arrhythmias, myocardial injury, cardiac function. Underlying pathways of Remote Ischemic Preconditioning in modifying the perioperative stress response.
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Endpoints were investigated in parallel in NCT00877305
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrick Meybohm
- Sponsor type
- University, hospital or other
- Collaborators
- Goethe University
- Responsible party
- Sponsor-investigator, Patrick Meybohm, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882622
- Sponsor's protocol ID
- A165/08_2
- Status last verified
- Jan 2012
- First submitted
- 14 Apr 2009
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00882622
- Acronym / sponsor ID
- A165/08_2
- Keywords
- Ischemic Preconditioning, Cardiac Surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Endpoints were investigated in parallel in NCT00877305
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Patrick MeybohmUniversity, hospital or other
- Collaborators
- Goethe University
- Study start
- Feb 2009
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 16 Apr 2009 (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.
The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cardiac function in patients undergoing cardiac surgery compared to control intervention.
Detailed description
In detail, we will focus on new onset of atrial fibrillation, ventricular arrhythmias, myocardial injury, and cardiac function. Furthermore, we aim to investigate underlying pathways of RIPC in modifying the perioperative stress response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC | Active comparator | Procedure: Remote Ischemic Preconditioning |
| CONTROL | Sham comparator | Procedure: Control/sham procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing heart surgery on cardiopulmonary bypass
Key exclusion criteria (4 listed)
- Emergency cases
- Myocardial infarction up to 7 days prior to enrollment
- Ejection fraction less than 30%
- Inability to give informed consent
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 PreconditioningRIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 15 mm Hg greater than the systolic arterial pressure measured via the arterial line. | Procedure or surgery | RIPC |
| Control/sham procedureSham placement of the blood pressure cuff around the upper limb without inflation. | Procedure or surgery | CONTROL |
Primary outcome
New onset of atrial fibrillation
Time frame: Within 30 days after surgery
1 secondary outcome
Ventricular arrhythmias, myocardial injury, cardiac function. Underlying pathways of Remote Ischemic Preconditioning in modifying the perioperative stress response.
Time frame: Within 24 hours after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Remote Ischemic Preconditioning in people with Atrial Fibrillation and Ventricular Arrythmias, run by Patrick Meybohm at 2 sites in Germany.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 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 2 sites in Germany. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
New onset of atrial fibrillation (time frame: Within 30 days after surgery). 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 18 Jan 2012.