Hip FractureNCT00647309
Troponin Elevation in the Elderly Patient With Hip Fracture
An observational study of Hip Fracture, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Elevated troponin is powerful and independent adverse prognostic marker in patient with ACS. However, non specific (non cardiac) troponin elevation is a common finding among hospitalized patients and worse prognosis too. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to Jun 2013
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: patients aged 65 years and over with hip fracture
Who may be able to join
- Age 65 and over with hip fracture
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center, Geriatric Rehabilitation dept
Ramat Gan, 52621
Arad Marina, MD, 973-3-5305108, aradm@post.tau.ac.il
arad marina, MD
About this study
Official title: Correlation Between Troponin Level and Rehabilitation Outcome in Elderly Patient With Hip Fracture
Elevated troponin is powerful and independent adverse prognostic marker in patient with ACS. However, non specific (non cardiac) troponin elevation is a common finding among hospitalized patients and worse prognosis too.
The aim of this study is examine the prevalence of incidental cardiac troponin rise in a group of patient aged 65 and over admitted to geriatric department with hip fracture, and influence of troponin elevation on outcomes like ACS, death, motor and cognitive function.
Read the detailed description
data collection will include epidemiological data (age, gender, living arrangement, basic functional status, fracture date, surgery date, surgery type, length of stay) as well as previous comorbidities. in addition, routine blood tests and baseline ECG will be recorded.
troponin levels will be studied within 24 hours from admission, and 24 hours following surgery. in case of elevated troponin levels, ECG will be repeated, and echocardiography together with a cardiologist evaluation will be carried out.
data regarding in-hospital complications, motor and cognitive function (by FIM scale) and lab will be recorded. after discharge. followup will be recorded every 3 months, up to 1 year period, recoding the above mentioned data.
- Conditions
- Hip Fracture
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality, motor and cognitive function
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Marina Arad, Sheba Medical Center
- Investigators
- Marina Arad, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647309
- Sponsor's protocol ID
- SHEBA-08-5096-MA-CTIL
- Status last verified
- Jun 2012
- First submitted
- 26 Mar 2008
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Troponin Level and Rehabilitation Outcome in Elderly Patient With Hip Fracture
- ClinicalTrials.gov ID
- NCT00647309
- Acronym / sponsor ID
- SHEBA-08-5096-MA-CTIL
- Conditions
- Hip Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Apr 2008
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 31 Mar 2008 (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.
Elevated troponin is powerful and independent adverse prognostic marker in patient with ACS. However, non specific (non cardiac) troponin elevation is a common finding among hospitalized patients and worse prognosis too.
The aim of this study is examine the prevalence of incidental cardiac troponin rise in a group of patient aged 65 and over admitted to geriatric department with hip fracture, and influence of troponin elevation on outcomes like ACS, death, motor and cognitive function.
Detailed description
data collection will include epidemiological data (age, gender, living arrangement, basic functional status, fracture date, surgery date, surgery type, length of stay) as well as previous comorbidities. in addition, routine blood tests and baseline ECG will be recorded.
troponin levels will be studied within 24 hours from admission, and 24 hours following surgery. in case of elevated troponin levels, ECG will be repeated, and echocardiography together with a cardiologist evaluation will be carried out.
data regarding in-hospital complications, motor and cognitive function (by FIM scale) and lab will be recorded. after discharge. followup will be recorded every 3 months, up to 1 year period, recoding the above mentioned data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients aged 65 years and over with hip fracture
Key inclusion criteria (1 listed)
- Age 65 and over with hip fracture
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all cause mortality, motor and cognitive function
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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.
Sheba Medical Center, Geriatric Rehabilitation dept
Ramat Gan, Israel
Marina Arad, MD principal investigator
Sheba Medical Center
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 Hip Fracture, run by Sheba Medical Center at 1 site in Israel.
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 1 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 12 Jun 2012. 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 Israel. 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?
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?
all cause mortality, motor and cognitive function (time frame: one year). 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 12 Jun 2012.