Quality of LifeNCT01654900
Mid-term Survival and Quality of Life of Elderly Patients Undergoing Open Heart Surgery
An observational study of Quality of Life, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purposes of the investigators study is to examine the overall survival and quality of life in elderly patients (> 75 years) undergoing open heart surgery at Hadassah medical center between 2008-2011. All alive patients will be phone interviewed using the 36-item short form health survey. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Quality of Life
- How many people
- 207 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2012to not given
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients age >75 y who underwent open heart surgery between 2008-2011 at hadassah medical center.
Who may be able to join
- all patients age > 75 years who discharged alive after surgery
Who cannot join
- death
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, Ein Kerem, 91120
Oz Shapira, MD, 00 972 2 6776960, ozshapira@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Mid -Term Survival and Quality of Life of Elderly Patients Undergoing Open Heart Surgery
The purposes of the investigators study is to examine the overall survival and quality of life in elderly patients (> 75 years) undergoing open heart surgery at Hadassah medical center between 2008-2011. All alive patients will be phone interviewed using the 36-item short form health survey. Results will be compared to similar health survey results (36-SF)obtained from a group of Israeli adults who had no open heart surgery (controlled group). The investigators hypothesize that elderly patients achieve improvement in quality of life after open heart surgery with acceptable operative morbidity and mortality.
- Conditions
- Quality of Life
- Being tested
- No intervention in this study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention in this studyOther
| Study group | Role | What they receive |
|---|---|---|
| Patients age >75 y who underwent open hear surgeary | The cohort study consist of all patients > 75 y, undergoing open heart surgery between 2008-2011 at Hadassah medical center. Receives: Other: No intervention in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: 2-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Retrospective
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oz Shapira, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654900
- Sponsor's protocol ID
- Heart90-HMO-CTIL
- Status last verified
- Jul 2012
- First submitted
- 16 Jul 2012
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid -Term Survival and Quality of Life of Elderly Patients Undergoing Open Heart Surgery
- ClinicalTrials.gov ID
- NCT01654900
- Acronym / sponsor ID
- Heart90-HMO-CTIL
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Oct 2012
- First posted
- 1 Aug 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.
The purposes of the investigators study is to examine the overall survival and quality of life in elderly patients (> 75 years) undergoing open heart surgery at Hadassah medical center between 2008-2011. All alive patients will be phone interviewed using the 36-item short form health survey. Results will be compared to similar health survey results (36-SF)obtained from a group of Israeli adults who had no open heart surgery (controlled group). The investigators hypothesize that elderly patients achieve improvement in quality of life after open heart surgery with acceptable operative morbidity and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients age >75 y who underwent open hear surgeary | – | Other: No intervention in this studyThe cohort study consist of all patients > 75 y, undergoing open heart surgery between 2008-2011 at Hadassah medical center. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients age >75 y who underwent open heart surgery between 2008-2011 at hadassah medical center.
Key inclusion criteria (1 listed)
- all patients age > 75 years who discharged alive after surgery
Key exclusion criteria (1 listed)
- death
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 |
|---|---|---|
| No intervention in this study | Other | Patients age >75 y who underwent open hear surgeary |
Primary outcome
Quality of life
Time frame: 2-4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 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.
Oz Shapira, MD principal investigator
Hadassah Medical Organization
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 Quality of Life, run by Hadassah Medical Organization 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 1 Aug 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?
Contact Oz Shapira, MD (00 972 2 6776960, ozshapira@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 2-4 years). 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 1 Aug 2012; AzTrials last refreshed its copy on 8 Nov 2026.