Heart FailureNCT00896142
Optima Coronary Artery Disease (CAD) (Optimal Mechanical Evaluation)
An observational study of Heart Failure and Ischemic Cardiomyopathy, run by University of Pittsburgh at 1 site in United States.
Trial summary
To evaluate the impact of left ventricular (LV) lead location on LV mechanical function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ischemic Cardiomyopathy
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18+ years of age must be patients of UPMC Cardiovascular Institute
Who may be able to join
- Ischemic Cardiomyopathy
- Left ventricular ejection fraction less than 40%
- Clinical indication for invasive electrophysiology testing
- Patient is at least 18 years of age
Who cannot join
- Unstable angina, acute myocardial infarction and/or revascularization procedure within 3 months
- CVA or TIA within the past 6 months
- Prosthetic heart valve
- Patient is status post heart transplant
- Women who are pregnant or with child -bearing potential and who are not on a reliable form of birth control. Women of child-bearing potential are routinely tested for pregnancy as part of the standard of care prior to EPS procedures being performed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optima CAD (Optimal Mechanical Evaluation)
To evaluate the impact of left ventricular (LV) lead location on LV mechanical function.
- Conditions
- Heart Failure, Ischemic Cardiomyopathy
- Keywords
- ischemic cardiomyopathy, cardiac resynchronization therapy, LV structure and function
- Medical subject headings
- Heart Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David S. Schwartzman, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896142
- Sponsor's protocol ID
- 0601112
- Status last verified
- Nov 2011
- First submitted
- 8 May 2009
- Last updated
- 22 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optima CAD (Optimal Mechanical Evaluation)
- ClinicalTrials.gov ID
- NCT00896142
- Acronym / sponsor ID
- 0601112
- Conditions
- Heart Failure, Ischemic Cardiomyopathy
- Keywords
- ischemic cardiomyopathy, cardiac resynchronization therapy, LV structure and function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Oct 2006
- First posted
- 11 May 2009 (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.
To evaluate the impact of left ventricular (LV) lead location on LV mechanical function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18+ years of age must be patients of UPMC Cardiovascular Institute
Key inclusion criteria (4 listed)
- Ischemic Cardiomyopathy
- Left ventricular ejection fraction less than 40%
- Clinical indication for invasive electrophysiology testing
- Patient is at least 18 years of age
Key exclusion criteria (5 listed)
- Unstable angina, acute myocardial infarction and/or revascularization procedure within 3 months
- CVA or TIA within the past 6 months
- Prosthetic heart valve
- Patient is status post heart transplant
- Women who are pregnant or with child -bearing potential and who are not on a reliable form of birth control. Women of child-bearing potential are routinely tested for pregnancy as part of the standard of care prior to EPS procedures being performed.
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
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 22 Nov 2011.
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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.
David S. Schwartzman, MD principal investigator
University of Pittsburgh
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 Heart Failure and Ischemic Cardiomyopathy, run by University of Pittsburgh 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 4 inclusion and 5 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 22 Nov 2011. 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 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 22 Nov 2011.