Coronary Artery DiseaseNCT01043237
Frequency Analysis of Coronary Artery Disease
An observational study of Coronary Artery Disease, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to determine if coronary artery disease can be detected using an electronic, acoustic recording instrument. The presence or absence of abnormal pathology will be confirmed by diagnostic angiography as part of the normal patient care at this institution. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Mar 2013
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the University of Minnesota Medical Center (UMMC) Fairview Clinics, Physicians (UMP) or the Redwing, Minnesota clinic
Who may be able to join
- Patients aged 18-89 years old and recommended for a cardiology related angiogram within 24 hours
Who cannot join
- Any patient less than 18 years of age or greater than 89 years of age.
- Any patient with any of the following conditions: pregnant or nursing, prior myocardial infarction, left ventricular device, heart transplant, valve replacement, congestive heart failure, atrial fibrillation (non-intermittent), endocarditis or any heart viral or bacterial infection, any patient who has or requires medication or other heart rhythm altering treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center (UMMC) Fairview Clinics
Minneapolis, Minnesota, 55455
About this study
Official title: A Single-centered Investigation Into the Frequency Domain Patterns in Vessels of Patients With Coronary Artery Disease
The purpose of this study is to determine if coronary artery disease can be detected using an electronic, acoustic recording instrument. The presence or absence of abnormal pathology will be confirmed by diagnostic angiography as part of the normal patient care at this institution.
- Conditions
- Coronary Artery Disease
- Keywords
- acoustic, digital, sound, vibration, coronary, auscultation, artery, diagnosis
- Medical subject headings
- Coronary Artery Disease, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine if coronary artery disease can be detected using an electronic, acoustic recording instrument
to determine if coronary artery disease can be detected using an electronic, acoustic recording instrument
Measured: Baselin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startMar 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Wilson, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043237
- Sponsor's protocol ID
- 0901M57884
- Status last verified
- Sep 2014
- First submitted
- 4 Jan 2010
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centered Investigation Into the Frequency Domain Patterns in Vessels of Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01043237
- Acronym / sponsor ID
- 0901M57884
- Conditions
- Coronary Artery Disease
- Keywords
- acoustic, digital, sound, vibration, coronary, auscultation, artery, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 6 Jan 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 determine if coronary artery disease can be detected using an electronic, acoustic recording instrument. The presence or absence of abnormal pathology will be confirmed by diagnostic angiography as part of the normal patient care at this institution.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the University of Minnesota Medical Center (UMMC) Fairview Clinics, Physicians (UMP) or the Redwing, Minnesota clinic
Key inclusion criteria (1 listed)
- Patients aged 18-89 years old and recommended for a cardiology related angiogram within 24 hours
Key exclusion criteria (2 listed)
- Any patient less than 18 years of age or greater than 89 years of age.
- Any patient with any of the following conditions: pregnant or nursing, prior myocardial infarction, left ventricular device, heart transplant, valve replacement, congestive heart failure, atrial fibrillation (non-intermittent), endocarditis or any heart viral or bacterial infection, any patient who has or requires medication or other heart rhythm altering treatment.
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
to determine if coronary artery disease can be detected using an electronic, acoustic recording instrument
Time frame: Baselin
to determine if coronary artery disease can be detected using an electronic, acoustic recording instrument
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 5 Sep 2014.
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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.
Robert Wilson, MD principal investigator
University of Minnesota
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 Artery Disease, run by University of Minnesota 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 2 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 5 Sep 2014. 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.
What does the primary outcome measure?
to determine if coronary artery disease can be detected using an electronic, acoustic recording instrument (time frame: Baselin). 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 5 Sep 2014.