Coronary DiseaseNCT01236313
Aortic Wall and Left Ventricular Mechanics: Echocardiographic and Hemodynamic Analysis
An observational study of Coronary Disease and Cardiac Valve Disease, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to prospectively determine the relationship between the dimensions of the aorta (the large artery taking off the heart) and blood pressure during cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Disease, Cardiac Valve Disease
- What is being tested?
- TEE report
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Mar 2014
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing bypass and/or valve surgery with general anesthesia
Who may be able to join
- elective CABG, valvular procedure
Who cannot join
- non-sinus rhythm (atrial fibrillation, flutter, paced rhythm), pre-operative presence of intra-aortic counterpulsation device, synthetic aortic graft.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
The purpose of this study is to prospectively determine the relationship between the dimensions of the aorta (the large artery taking off the heart) and blood pressure during cardiac surgery.
Read the detailed description
The purpose of this study is to prospectively determine the relationship between the dimensions of the aorta (the large artery taking off the heart) and blood pressure during cardiac surgery. Measurements of the aorta are obtained by an ultrasound-based imaging technique called transesophageal echocardiography (TEE), which is routinely performed during cardiac surgery. TEE is an instrument used to monitor the heart and is standard of practice at Weill Cornell Medical College.
- Conditions
- Coronary Disease, Cardiac Valve Disease
- Being tested
- TEE report
- Keywords
- TEE, Cardiac Surgery, Pulse Pressure
- Medical subject headings
- Coronary Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEE reportProcedure or surgery
Information will be collected during cardiac surgery.
| Study group | Role | What they receive |
|---|---|---|
| TEE report | Cardiac surgery patients requiring TEE Receives: Procedure: TEE report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the dimensions of the aorta and compare with blood pressure measurements
Measured: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Insufficient recruitment to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaos Skubas, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236313
- Sponsor's protocol ID
- 1005011039
- Status last verified
- Feb 2016
- First submitted
- 4 Nov 2010
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Wall and Left Ventricular Mechanics: Echocardiographic and Hemodynamic Analysis
- ClinicalTrials.gov ID
- NCT01236313
- Acronym / sponsor ID
- 1005011039
- Conditions
- Coronary Disease, Cardiac Valve Disease
- Keywords
- TEE, Cardiac Surgery, Pulse Pressure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment to complete study
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Nov 2010 (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 purpose of this study is to prospectively determine the relationship between the dimensions of the aorta (the large artery taking off the heart) and blood pressure during cardiac surgery.
Detailed description
The purpose of this study is to prospectively determine the relationship between the dimensions of the aorta (the large artery taking off the heart) and blood pressure during cardiac surgery. Measurements of the aorta are obtained by an ultrasound-based imaging technique called transesophageal echocardiography (TEE), which is routinely performed during cardiac surgery. TEE is an instrument used to monitor the heart and is standard of practice at Weill Cornell Medical College.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEE report | – | Procedure: TEE reportCardiac surgery patients requiring TEE |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing bypass and/or valve surgery with general anesthesia
Key inclusion criteria (1 listed)
- elective CABG, valvular procedure
Key exclusion criteria (1 listed)
- non-sinus rhythm (atrial fibrillation, flutter, paced rhythm), pre-operative presence of intra-aortic counterpulsation device, synthetic aortic graft.
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 |
|---|---|---|
| TEE reportInformation will be collected during cardiac surgery. | Procedure or surgery | TEE report |
Primary outcome
Measure the dimensions of the aorta and compare with blood pressure measurements
Time frame: 1
Results and safety
The study was stopped early (reason given: Insufficient recruitment to complete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
Nikolaos Skubas, M.D. principal investigator
Weill Medical College of Cornell University
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 Coronary Disease and Cardiac Valve Disease, run by Weill Medical College of Cornell University at 1 site in United States.
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: stopped early, as of the sponsor's last update on 18 Feb 2016. 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 United States. 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 was stopped early (reason given: Insufficient recruitment to complete study). Results are not available in the source record.
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.
What does the primary outcome measure?
Measure the dimensions of the aorta and compare with blood pressure measurements (time frame: 1). 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 18 Feb 2016.