- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00248898
Quality of Life After Open Heart Surgery in Older Patients
January 18, 2017 updated by: Weill Medical College of Cornell University
Long term follow-up of nonagenarians who have undergone open heart procedures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Based on population studies, life expectancy at age 80 is 8.5 years, and at the age of 85 years, it is 6.3 years (US Bureau of Census 2000).
There are currently 1.6 million nonagenarians and roughly 72,000 centenarians living in the United States.
With this increasing elderly population, knowledge of the special management issues and long-term sequela are imperative.
Bacchetta and coworkers from our institution presented a 10-year outcomes experience in nonagenarians undergoing cardiac surgery.
In 42 consecutive patients, in-hospital mortality was 7%, and 30-day mortality 5%.
Postoperative morbidity was documented in 67% with arrhythmias accounting for 31% of the cases, followed by respiratory complications, infections, and strokes.
While this is mostly in-hospital data, long-term follow-ups have not been performed.
Study Type
Observational
Enrollment (Actual)
49
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10021
- The New York Presbyterian Hospital - Weill Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
90 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A (consecutive) series of 49 patients age 90 years or older underwent cardiac operations between May 1995 and October 2004 at New York Presbyterian Hospital-Weill Medical College of Cornell University.
Description
Inclusion Criteria:
- Patients who underwent open heart procedures and who were 90 years or greater between 1995 and 2004 at The New York Presbyterian Hospital
Exclusion Criteria:
- Patients who refuse follow-up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Karl H Krieger, MD, Weill Medical College of Cornell University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (ACTUAL)
December 1, 2005
Study Completion (ACTUAL)
December 1, 2005
Study Registration Dates
First Submitted
November 3, 2005
First Submitted That Met QC Criteria
November 3, 2005
First Posted (ESTIMATE)
November 4, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
January 20, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 0501007700
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Investigators may contact the PI for access to the data, with their planned analyses
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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