Ischemic CardiopathyNCT00408044
Dysesthesia Study After Sternotomy
An observational study of Ischemic Cardiopathy and Other Forms of Cardiopathy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Chronic pain associated to sternotomy occurs in 40 to 50% of patients after cardiac surgery. 33 to 66% of these patients suffer during 3 month and 25 to 33% have postoperative pain for at least 1 year. This pain has often negative effects on daily activity. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Cardiopathy, Other Forms of Cardiopathy
- What is being tested?
- cardiac surgery with sternotomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2006to Mar 2007
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiac surgery with sternotomy
Who cannot join
- patients with chronic pain
- redo surgery
- patients with neurological pathologies
- patients treated with antidepressant medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain After Sternotomy
Chronic pain associated to sternotomy occurs in 40 to 50% of patients after cardiac surgery.
33 to 66% of these patients suffer during 3 month and 25 to 33% have postoperative pain for at least 1 year.
Read more
This pain has often negative effects on daily activity. Despite its frequency and importance, the etiology of this chronic pain is not completely understood.
The goal of this study is to understand the mechanism of this chronic pain, to prevent and/or to treat better in the future.
The sensitivity of the thorax after cardiac surgery seems to follow a dynamic evolution which can be observed within several weeks. Therefore we decided to study this evolution.
This study is different from previous ones observing the sensitivity of the thorax at a well defined moment immediately after the surgery.
- Conditions
- Ischemic Cardiopathy, Other Forms of Cardiopathy
- Being tested
- cardiac surgery with sternotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgery with sternotomyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionFeb 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiopathyStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Investigators
- Mona Momeni, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408044
- Sponsor's protocol ID
- CE 2005/05SEPT/134
- Status last verified
- May 2008
- First submitted
- 4 Dec 2006
- Last updated
- 20 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain After Sternotomy
- ClinicalTrials.gov ID
- NCT00408044
- Acronym / sponsor ID
- CE 2005/05SEPT/134
- Conditions
- Ischemic Cardiopathy, Other Forms of Cardiopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 5 Dec 2006 (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.
Chronic pain associated to sternotomy occurs in 40 to 50% of patients after cardiac surgery.
33 to 66% of these patients suffer during 3 month and 25 to 33% have postoperative pain for at least 1 year.
This pain has often negative effects on daily activity. Despite its frequency and importance, the etiology of this chronic pain is not completely understood.
The goal of this study is to understand the mechanism of this chronic pain, to prevent and/or to treat better in the future.
The sensitivity of the thorax after cardiac surgery seems to follow a dynamic evolution which can be observed within several weeks. Therefore we decided to study this evolution.
This study is different from previous ones observing the sensitivity of the thorax at a well defined moment immediately after the surgery.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac surgery with sternotomy
Key exclusion criteria (4 listed)
- patients with chronic pain
- redo surgery
- patients with neurological pathologies
- patients treated with antidepressant medication
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 |
|---|---|---|
| cardiac surgery with sternotomy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 20 May 2008.
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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.
Mona Momeni, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Cardiopathy and Other Forms of Cardiopathy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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: finished, as of the sponsor's last update on 20 May 2008. 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 Belgium. 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.
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 20 May 2008.