Aortic AneurysmPhase 1NCT01523262
Preventing Myocardial Ischemia by Preconditioning in Elective Operation for Abdominal Aortic Aneurysm
A Phase 1 study testing preconditioning in people with Aortic Aneurysm, run by Aarhus University Hospital at 2 sites in Denmark.
Trial summary
Primary To investigate whether peripheral predonditioning induced by brief, intermittent constriction of blood supply to an arm can reduce the incidence of perioperative myocardial ischemia in patients operated electively for infrarenal aortic aneurysm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2011to Jan 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients older than 18 years, hospitalized for elective surgery of abdominal aortic aneurysm
Who cannot join
- Lack of informed consent.
- Hemiparetic patient.
- Pregnancy or nursing patient.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aalborg Hospital
Aalborg, Aalborg, 9000
Troels F Pedersen, MD, troels.fogh@ki.au.dk
Troels F Pedersen, MD
- Recruiting
Aarhus University Hospital, Skejby
Aarhus, Aarhus N, 8200
Nikolaj Eldrup, eldrup@clin.au.dk
Nikolaj Eldrup, MD, PHD
About this study
Official title: The Effect of Preconditioning to Prevent Perioperative Myocardial Ischemia in Elective Operation of Abdominal Aortic Aneurysm
Primary To investigate whether peripheral predonditioning induced by brief, intermittent constriction of blood supply to an arm can reduce the incidence of perioperative myocardial ischemia in patients operated electively for infrarenal aortic aneurysm.
Secondary To investigate the impact of peripheral preconditioning on perioperative inflammatory response.
To investigate whether peripheral preconditoning can protect against perioperative myocardial infarction and reduced cardiac pump function.
- Conditions
- Aortic Aneurysm
- Being tested
- preconditioning, Normal surgery, with sham intervention without inflating arm cuff
- Keywords
- preconditioning, aortic aneurysm
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preconditioningProcedure or surgery
peripheral preconditioning induced by brief, intermittent constriction of blood supply to an arm
Normal surgery, with sham intervention without inflating arm cuffProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Preconditioning and normal treatment | Active comparator | Not described Receives: Procedure: preconditioning |
| normal treatment | Placebo comparator | Standard treatment Receives: Procedure: Normal surgery, with sham intervention without inflating arm cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurements of CKMB and Troponin T
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2015 (estimated)
- Study completionJan 2016 (estimated)
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 Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaj Eldrup, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523262
- Sponsor's protocol ID
- M-20100012
- Status last verified
- Jan 2015
- First submitted
- 30 Jan 2012
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
PubMed 36645250
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preconditioning to Prevent Perioperative Myocardial Ischemia in Elective Operation of Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT01523262
- Acronym / sponsor ID
- M-20100012
- Conditions
- Aortic Aneurysm
- Keywords
- preconditioning, aortic aneurysm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 1 Feb 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.
Primary To investigate whether peripheral predonditioning induced by brief, intermittent constriction of blood supply to an arm can reduce the incidence of perioperative myocardial ischemia in patients operated electively for infrarenal aortic aneurysm.
Secondary To investigate the impact of peripheral preconditioning on perioperative inflammatory response.
To investigate whether peripheral preconditoning can protect against perioperative myocardial infarction and reduced cardiac pump function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preconditioning and normal treatment | Active comparator | Procedure: preconditioning |
| normal treatment | Placebo comparator | Procedure: Normal surgery, with sham intervention without inflating arm cuffStandard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients older than 18 years, hospitalized for elective surgery of abdominal aortic aneurysm
Key exclusion criteria (3 listed)
- Lack of informed consent.
- Hemiparetic patient.
- Pregnancy or nursing patient.
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 |
|---|---|---|
| preconditioningperipheral preconditioning induced by brief, intermittent constriction of blood supply to an arm | Procedure or surgery | Preconditioning and normal treatment |
| Normal surgery, with sham intervention without inflating arm cuff | Procedure or surgery | normal treatment |
Primary outcome
measurements of CKMB and Troponin T
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- Derived from this study: PubMed 36645250Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.
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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.
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 preconditioning in people with Aortic Aneurysm, run by Aarhus University Hospital at 2 sites in Denmark.
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 3 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 14 Jan 2015. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurements of CKMB and Troponin T (time frame: 30 days). 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 NCT01523262, 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 14 Jan 2015.