Coronary Artery DiseaseNCT01564628
Data Acquisition for Optimization of Coronary Artery Disease (CAD) Algorithm
An observational study of Coronary Artery Disease, run by Acarix at 1 site in Denmark.
Trial summary
The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CADScor1
- Type of treatment
- Medical device
- How many people
- 306 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Oct 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to examination for Coronary Artery Disease
Who may be able to join
- At least 18 years old
- Referred to diagnostically Ca-CT, CT scan and/or CAG examination due to suspicion of coronary artery disease
- Subjects condition must be stable and the subject must not be referred due to suspicion of acute coronary syndrome
- Subject is willing to adhere to the study procedure
- Has signed the informed consent form and authorization to registration and publication of health information
Who cannot join
- Has acute coronary syndrome or stroke
- Arterial fibrillation
- Known severe arrhythmia or resting heart rate above 85 bpm
- Known diastolic murmurs due to heart valve disease
- Has had a previous by-pass operation, open chest surgery, donor heart or mechanical heart
- Reduced ejection fraction < 50%
Show all 12Show fewer
- Inability to understand or adhere to instructions for acoustic Data-acquisition (i.e. subject not able to hold breath due to KOL or asthma)
- Inability to perform CT-angio and/or subsequent CAG
- In active treatment for any cancer
- In active treatment for immunosuppression after transplantation
- Established or pursuing pregnancy or breast feeding
- Has damaged skin on the spot where the patch is placed during the recordings.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Data Acquisition for Optimization of Coronary Artery Disease Algorithm
The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).
Read the detailed description
Acoustic information from the heart is obtained from patients referred to examination for Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.
- Conditions
- Coronary Artery Disease
- Being tested
- CADScor1
- Keywords
- CAD
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADScor1Device
Acoustic recording
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Population from 2 sites, sequential design with all patients undergoing CADScor1 intervention followed by the diagnostic testing the patients were referred to (procedure done according to standard of care and not part of study; computerized tomographic angiography (CTA) and, if relevant, coronary angiography (CAG) at Site 1 and CAG at site 2). Receives: Device: CADScor1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients.
Cardiac noise marker (CAD-score) ability to separate CAD from non-CAD patients is estimated as the area under the receiver operating characteristic curve.
The area under the receiver operating characteristic curve is plottet as sensitivity versus 1-specificity as a function of different CAD-score cut-off values.
The area under the receiver operating characteristic curve is on a scale from 0-100%, the higher value means a better separation of CAD from non-CAD patients.
CAD and non-CAD patients are defined by the CTA and CAG evaluations.
Measured: Heart sound recordings measured on testday (25 minutes study period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acarix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Morten Bøttcher, MD, Principal investigator, University Hospital of Aarhus, Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564628
- Sponsor's protocol ID
- AC003-SH
- Status last verified
- Jul 2019
- First submitted
- 21 Mar 2012
- Last updated
- 19 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Acquisition for Optimization of Coronary Artery Disease Algorithm
- ClinicalTrials.gov ID
- NCT01564628
- Acronym / sponsor ID
- AC003-SH
- Conditions
- Coronary Artery Disease
- Keywords
- CAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- AcarixIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Posted 19 Aug 2019
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 the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).
Detailed description
Acoustic information from the heart is obtained from patients referred to examination for Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | – | Device: CADScor1Population from 2 sites, sequential design with all patients undergoing CADScor1 intervention followed by the diagnostic testing the patients were referred to (procedure done according to standard of care and not part of study; computerized tomographic angiography (CTA) and, if relevant, coronary angiography (CAG) at Site 1 and CAG at site 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to examination for Coronary Artery Disease
Key inclusion criteria (5 listed)
- At least 18 years old
- Referred to diagnostically Ca-CT, CT scan and/or CAG examination due to suspicion of coronary artery disease
- Subjects condition must be stable and the subject must not be referred due to suspicion of acute coronary syndrome
- Subject is willing to adhere to the study procedure
- Has signed the informed consent form and authorization to registration and publication of health information
Key exclusion criteria (12 listed)
- Has acute coronary syndrome or stroke
- Arterial fibrillation
- Known severe arrhythmia or resting heart rate above 85 bpm
- Known diastolic murmurs due to heart valve disease
- Has had a previous by-pass operation, open chest surgery, donor heart or mechanical heart
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 |
|---|---|---|
| CADScor1Acoustic recording | Device | All study participants |
Primary outcome
The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients.
Time frame: Heart sound recordings measured on testday (25 minutes study period)
Cardiac noise marker (CAD-score) ability to separate CAD from non-CAD patients is estimated as the area under the receiver operating characteristic curve. The area under the receiver operating characteristic curve is plottet as sensitivity versus 1-specificity as a function of different CAD-score cut-off values. The area under the receiver operating characteristic curve is on a scale from 0-100%, the higher value means a better separation of CAD from non-CAD patients. CAD and non-CAD patients are defined by the CTA and CAG evaluations.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Coronary Artery Disease
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Not yet recruitingPhase 3
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Heart Failure Due to Coronary Artery Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingObservational study
Cardiovascular Acoustics for Early Disease Detection
Valvular Heart Disease, Coronary Artery Disease
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.
Morten Bøttcher, MD principal investigator
University Hospital of Aarhus, Skejby
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 Acarix at 1 site in Denmark.
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 5 inclusion and 12 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 19 Aug 2019. 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 Denmark. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients. (time frame: Heart sound recordings measured on testday (25 minutes study period)). 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 19 Aug 2019.