Ischemic Heart DiseaseDASI-08-713NCT00907855
Using Duke Activity Status Index (DASI) to Select Optimal Cardiac Stress Tests
An observational study of Ischemic Heart Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
Cardiac stress testing with functional nuclear imaging is an invaluable technique in the diagnostic and prognostic evaluation of patients with known or suspected ischemic heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to 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: Patients referred by their primary physician to the Nuclear Lab at NYU School of Medicine for stress myocardial perfusion imaging testing.
Who may be able to join
- Age > 18
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nuclear Cardiology/Stress Lab, NYU Cardiology Division
New York, New York, 10016
About this study
Official title: Clinical Role of the Duke Activity Status Index in the Selection of the Optimal Type of Stress Myocardial Perfusion Imaging Study in Patients With Known or Suspected Ischemic Heart Disease
Cardiac stress testing with functional nuclear imaging is an invaluable technique in the diagnostic and prognostic evaluation of patients with known or suspected ischemic heart disease. Selection of the appropriate type of nuclear stress test: exercise stress Myocardial Perfusion Imaging (MPI) versus pharmacologic stress MPI is crucial for not only diagnostic accuracy and prognostic evaluation, but also for sound clinical decisions and resource utilization.
The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs) and has been shown to be a valid measurement of functional capacity. The investigators hypothesized that the DASI may be the screening tool that evaluates functional capacity and guides selection of the optimal stress MPI study.
- Conditions
- Ischemic Heart Disease
- Keywords
- Ischemic Heart Disease, Duke Activity Status Index, Stress Myocardial Perfusion Imaging
- Medical subject headings
- Myocardial Ischemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, Lawrence Phillips, MD, NYU Langone Health
- Investigators
- Jennifer H. Mieres, MD, Principal investigator, Division of Cardiology, New York University School of MedicineLawrence Phillips, MD, Study director, Division of Cardiology, New York University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907855
- Sponsor's protocol ID
- NYU DASI 08-713
- Acronym
- DASI-08-713
- Status last verified
- Nov 2011
- First submitted
- 22 May 2009
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Shaw LJ, Olson MB, Kip K, Kelsey SF, Johnson BD, Mark DB, Reis SE, Mankad S, Rogers WJ, Pohost GM, Arant CB, Wessel TR, Chaitman BR, Sopko G, Handberg E, Pepine CJ, Bairey Merz CN. The value of estimated functional capacity in estimating outcome: results from the NHBLI-Sponsored Women's Ischemia Syndrome Evaluation (WISE) Study. J Am Coll Cardiol. 2006 Feb 7;47(3 Suppl):S36-43. doi: 10.1016/j.jacc.2005.03.080.
PubMed 16458169Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7.
PubMed 2782256
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Role of the Duke Activity Status Index in the Selection of the Optimal Type of Stress Myocardial Perfusion Imaging Study in Patients With Known or Suspected Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT00907855
- Acronym / sponsor ID
- DASI-08-713 / NYU DASI 08-713
- Conditions
- Ischemic Heart Disease
- Keywords
- Ischemic Heart Disease, Duke Activity Status Index, Stress Myocardial Perfusion Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Apr 2009
- First posted
- 25 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.
Cardiac stress testing with functional nuclear imaging is an invaluable technique in the diagnostic and prognostic evaluation of patients with known or suspected ischemic heart disease. Selection of the appropriate type of nuclear stress test: exercise stress Myocardial Perfusion Imaging (MPI) versus pharmacologic stress MPI is crucial for not only diagnostic accuracy and prognostic evaluation, but also for sound clinical decisions and resource utilization.
The Duke Activity Status Index (DASI) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (METs) and has been shown to be a valid measurement of functional capacity. The investigators hypothesized that the DASI may be the screening tool that evaluates functional capacity and guides selection of the optimal stress MPI study.
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
- Patients referred by their primary physician to the Nuclear Lab at NYU School of Medicine for stress myocardial perfusion imaging testing.
Key inclusion criteria (1 listed)
- Age > 18
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
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 30 Nov 2011.
- Background: PubMed 16458169Shaw LJ, Olson MB, Kip K, Kelsey SF, Johnson BD, Mark DB, Reis SE, Mankad S, Rogers WJ, Pohost GM, Arant CB, Wessel TR, Chaitman BR, Sopko G, Handberg E, Pepine CJ, Bairey Merz CN. The value of estimated functional capacity in estimating outcome: results from the NHBLI-Sponsored Women's Ischemia Syndrome Evaluation (WISE) Study. J Am Coll Cardiol. 2006 Feb 7;47(3 Suppl):S36-43. doi: 10.1016/j.jacc.2005.03.080.
- Background: PubMed 2782256Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7.
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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.
Jennifer H. Mieres, MD principal investigator
Division of Cardiology, New York University School of Medicine
Lawrence Phillips, MD study director
Division of Cardiology, New York University School of Medicine
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 Ischemic Heart Disease, run by NYU Langone Health 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: finished, as of the sponsor's last update on 30 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?
On the ClinicalTrials.gov record for NCT00907855, which also lists 2 linked publications.
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 30 Nov 2011; AzTrials last refreshed its copy on 5 Nov 2026.