Coronary Artery DiseaseNCT06655779
Performance of the Acoustic Based CADScor System in Coronary Artery Disease
An observational study of Coronary Artery Disease and Angina (stable), run by INTEGRIS Baptist Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if the CAD Score, collected from the CADscore system, performs as well as the Coronary CTA in determining Coronary Artery Disease, in low to intermediate risk patients that are referred for coronary CTA. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Angina (stable)
- What is being tested?
- Acoustic Detection of Blood Flow
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2024to Mar 2026
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects to be recruited from INTEGRIS Baptist Medical Center.
Who may be able to join
- Signed ICF
- Male or female, aged 30 years or above
- Symptoms suggestive of stable coronary artery disease
- No history of coronary artery disease(prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft).
Who cannot join
- Asymptomatic for angina or chest pain
- Implanted donor heart
- Previous Coronary Artery Bypass Graft(CABG)
- Previous Coronary Stenting or known CAD
- Arrhythmia causing non-sinus rhythm
- Fragile or compromised skin, or abnormal anatomy or significant operation scars in the fourth left int3er Costal 9IC4-L) recording area
- Implanted mechanical heart or mechanical heart pump
- Implanted pacemaker or Cardioverter Defibrillator(ICD), other implanted active electronics or act5ive electronic support equipment closer than 50 cm to the CADScore System.
Trial locations and contacts
1 site in 1 country.
United States1 site
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Jill Fife, RN, 405-951-8607, bethany.fife@integrishealth.org
Linda Pitchford, RN, APRN, 405-949-3648, linda.pitchford@integrishealth.org
About this study
The purpose of this study is to determine if the CAD Score, collected from the CADscore system, performs as well as the Coronary CTA in determining Coronary Artery Disease, in low to intermediate risk patients that are referred for coronary CTA.
- Conditions
- Coronary Artery Disease, Angina (stable)
- Being tested
- Acoustic Detection of Blood Flow
- Keywords
- CADScore
- Medical subject headings
- Coronary Artery Disease, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic Detection of Blood FlowDiagnostic test
Subject will have the acoustic device scoring performed prior to a Coronary CTA. No treatment decisions will be based upon the acoustic device score.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
To determine that the sensitivity of the CAD score in low to intermediate-risk patients referred for coronary CTA in non-inferior to the device specified sensitivity at 89%.
Measured: From enrollment through 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- INTEGRIS Baptist Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, INTEGRIS Cardiovascular Research, INTEGRIS Baptist Medical Center
- Investigators
- Jon P Blaschke, MD, Principal investigator, INTEGRIS Baptist Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655779
- Sponsor's protocol ID
- Integrisbmc
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Acoustic Based CADScor System in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06655779
- Acronym / sponsor ID
- Integrisbmc
- Conditions
- Coronary Artery Disease, Angina (stable)
- Keywords
- CADScore
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- INTEGRIS Baptist Medical CenterUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 23 Oct 2024 (actual)
- 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 the CAD Score, collected from the CADscore system, performs as well as the Coronary CTA in determining Coronary Artery Disease, in low to intermediate risk patients that are referred for coronary CTA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects to be recruited from INTEGRIS Baptist Medical Center.
Key inclusion criteria (4 listed)
- Signed ICF
- Male or female, aged 30 years or above
- Symptoms suggestive of stable coronary artery disease
- No history of coronary artery disease(prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft).
Key exclusion criteria (8 listed)
- Asymptomatic for angina or chest pain
- Implanted donor heart
- Previous Coronary Artery Bypass Graft(CABG)
- Previous Coronary Stenting or known CAD
- Arrhythmia causing non-sinus rhythm
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 |
|---|---|---|
| Acoustic Detection of Blood FlowSubject will have the acoustic device scoring performed prior to a Coronary CTA. No treatment decisions will be based upon the acoustic device score. | Diagnostic test | – |
Primary outcome
Primary Objective
Time frame: From enrollment through 1 year
To determine that the sensitivity of the CAD score in low to intermediate-risk patients referred for coronary CTA in non-inferior to the device specified sensitivity at 89%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Jon P Blaschke, MD principal investigator
INTEGRIS Baptist Medical Center
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 and Angina (stable), run by INTEGRIS Baptist Medical Center 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 8 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: status not confirmed, as of the sponsor's last update on 23 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jill Fife, RN (405-951-8607, bethany.fife@integrishealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: From enrollment through 1 year). 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 23 Oct 2024.