Coronary Artery DiseaseSEQUELNCT03793049
Repeatability and Reproducibility of the CADence™System
An observational study of Coronary Artery Disease, run by AUM Cardiovascular, Inc. at 3 sites in United States.
Trial summary
This study is designed as a prospective study to capture data for evaluating the repeatability and reproducibility of the CADence™ System. The study will be conducted at 3 different study sites using 6 CADence™ systems. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CADence testing will be performed
- Type of treatment
- Medical device
- How many people
- 79 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Jan 2019to 26 Jun 2019
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with chest pain and 2 or more coronary artery disease risk factors
Who may be able to join
- Subjects clinically indicated for nuclear stress test and who satisfy all the inclusion and exclusion criteria are eligible for participation.
- Age 22 years or older
- Willing and able to give informed consent
- Clinical indication for nuclear stress test evaluation
- Chest pain syndrome
- Two or more coronary artery disease risk factors as defined by:
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- Dyslipidemia: LDL >130 mm/dL or HDL <35 mm/dL or on treatment for dyslipidemia
- Hypertension: blood pressure >140 mmHg systolic, >90 mmHg diastolic or on blood pressure altering treatment
- Obesity: BMI>28
- Current cigarette smoking
- Diabetes: Type 1 or 2
- Family history: coronary disease in a first or second degree relative
- Age 22 years or older
- Willing and able to give informed consent
- Clinical indication for nuclear stress test evaluation
- Chest pain syndrome
- Two or more coronary artery disease risk factors as defined by:
- Dyslipidemia: LDL >130 mm/dL or HDL <35 mm/dL or on treatment for dyslipidemia
- Hypertension: blood pressure >140 mmHg systolic, >90 mmHg diastolic or on blood pressure altering treatment
- Obesity: BMI>28
- Current cigarette smoking
- Diabetes: Type 1 or 2
- Family history: coronary disease in a first or second degree relative
Who cannot join
- Subjects clinically indicated for nuclear stress test and who satisfy all the inclusion and exclusion criteria are eligible for participation.
- Body Mass Index (BMI)<18.5 or BMI >40
- Known coronary disease as defined as:
- Prior bypass surgery or coronary stenting
- Q-wave infarction on a past EKG (>0.01 sec Q-wave duration in two adjacent leads)
- Presence of pacemaker/defibrillator
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- Presence of artificial valve
- Presence of obvious cyanotic or pre-diagnosed congenital heart defect and coarctation of the aorta
- The presence of murmurs including moderate to severe valve disease, ventricular septal defects, and AV fistulae
- Presence of moderate or severe valve disease as defined by >1/6 heart murmur on physical diagnosis
- Left Ventricular Assist Device (LVAD)
- Presence of scars on the site thorax areas
- Participation in trial within 30 days prior to collecting CADenceTM data except participation in registry studies
- Asthma with wheezing
- Inability to lie flat in the supine position
- Acute coronary syndrome with elevated cardiac biomarkers (TP>3x upper limit of normal (ULN) or CKMB>3x ULN)
- Heart transplant
- Current cocaine use (within the past 24 hours, as reported by subject)
- Chronic Obstructive Pulmonary Disease (COPD)
- Patient is not an acceptable candidate for CT angiography:
- Renal failure with GFR <50
- Iodinated contrast allergy
- Elevated heart rate which cannot be controlled sufficiently to achieve a good CT angiogram
- Body weight >350lbs
- Persistent sinus rhythm abnormalities (e.g., atrial fibrillation) based on medical history.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
910 Medical
Minneapolis, Minnesota, 55455
Northfield Urgent Care Clinic
Northfield, Minnesota, 55057
Pivot Point Medical
Northfield, Minnesota, 55057
About this study
This study is designed as a prospective study to capture data for evaluating the repeatability and reproducibility of the CADence™ System. The study will be conducted at 3 different study sites using 6 CADence™ systems. Each subject will be tested 4 separate times by 2 different operators at each site and will be tested at all 3 site locations in order to accomplish this evaluation. The study will enroll a total of at least 24 CADence positive patients and at least 24 CADence negative patients.
Read the detailed description
The CADence™ system is comprised of a digital stethoscope used to record cardiac (heart) sounds, with integrated sensor used to record electrical activity of the heart (ECG), a single-use patient booklet, and the CADence™ Software application. CADence™ Software is a clinical decision support tool for the noninvasive functional evaluation of patients presenting with chest pain and at least two coronary artery disease risk factors that is intended to aid a qualified clinician's analysis of normal/physiological and pathological heart murmurs and in ruling out significant coronary disease as a cause for these symptoms of cardiovascular disease, utilizing simultaneous recording of cardiac sounds and ECG.
The purpose of this study is to assess the precision of the CADence site using multiple operators, cadence systems and clinical sites.
- Conditions
- Coronary Artery Disease
- Being tested
- CADence testing will be performed
- Keywords
- acoustic, ECG
- 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.
CADence testing will be performedDevice
CADence is a noninvasive, handheld device comprised of acoustic and ECG technology and software
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Percent Agreement and Negative Percent Agreement
repeatability and reproducibility
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start23 Jan 2019
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- AUM Cardiovascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ROBERT WILSON, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793049
- Sponsor's protocol ID
- 1030-002-03
- Acronym
- SEQUEL
- Status last verified
- Jan 2019
- First submitted
- 2 Jan 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: WILL NOT BE SHARED
Publications
Neglia D, Rovai D, Caselli C, Pietila M, Teresinska A, Aguade-Bruix S, Pizzi MN, Todiere G, Gimelli A, Schroeder S, Drosch T, Poddighe R, Casolo G, Anagnostopoulos C, Pugliese F, Rouzet F, Le Guludec D, Cappelli F, Valente S, Gensini GF, Zawaideh C, Capitanio S, Sambuceti G, Marsico F, Perrone Filardi P, Fernandez-Golfin C, Rincon LM, Graner FP, de Graaf MA, Fiechter M, Stehli J, Gaemperli O, Reyes E, Nkomo S, Maki M, Lorenzoni V, Turchetti G, Carpeggiani C, Marinelli M, Puzzuoli S, Mangione M, Marcheschi P, Mariani F, Giannessi D, Nekolla S, Lombardi M, Sicari R, Scholte AJ, Zamorano JL, Kaufmann PA, Underwood SR, Knuuti J; EVINCI Study Investigators. Detection of significant coronary artery disease by noninvasive anatomical and functional imaging. Circ Cardiovasc Imaging. 2015 Mar;8(3):e002179. doi: 10.1161/CIRCIMAGING.114.002179.
PubMed 25711274
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability and Reproducibility of the CADence™System
- ClinicalTrials.gov ID
- NCT03793049
- Acronym / sponsor ID
- SEQUEL / 1030-002-03
- Conditions
- Coronary Artery Disease
- Keywords
- acoustic, ECG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- AUM Cardiovascular, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 4 Jan 2019 (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.
This study is designed as a prospective study to capture data for evaluating the repeatability and reproducibility of the CADence™ System. The study will be conducted at 3 different study sites using 6 CADence™ systems. Each subject will be tested 4 separate times by 2 different operators at each site and will be tested at all 3 site locations in order to accomplish this evaluation. The study will enroll a total of at least 24 CADence positive patients and at least 24 CADence negative patients.
Detailed description
The CADence™ system is comprised of a digital stethoscope used to record cardiac (heart) sounds, with integrated sensor used to record electrical activity of the heart (ECG), a single-use patient booklet, and the CADence™ Software application. CADence™ Software is a clinical decision support tool for the noninvasive functional evaluation of patients presenting with chest pain and at least two coronary artery disease risk factors that is intended to aid a qualified clinician's analysis of normal/physiological and pathological heart murmurs and in ruling out significant coronary disease as a cause for these symptoms of cardiovascular disease, utilizing simultaneous recording of cardiac sounds and ECG.
The purpose of this study is to assess the precision of the CADence site using multiple operators, cadence systems and clinical sites.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chest pain and 2 or more coronary artery disease risk factors
Key inclusion criteria (23 listed)
- Subjects clinically indicated for nuclear stress test and who satisfy all the inclusion and exclusion criteria are eligible for participation.
- Age 22 years or older
- Willing and able to give informed consent
- Clinical indication for nuclear stress test evaluation
- Chest pain syndrome
Key exclusion criteria (25 listed)
- Subjects clinically indicated for nuclear stress test and who satisfy all the inclusion and exclusion criteria are eligible for participation.
- Body Mass Index (BMI)<18.5 or BMI >40
- Known coronary disease as defined as:
- Presence of pacemaker/defibrillator
- Presence of artificial valve
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 |
|---|---|---|
| CADence testing will be performedCADence is a noninvasive, handheld device comprised of acoustic and ECG technology and software | Device | – |
Primary outcome
Positive Percent Agreement and Negative Percent Agreement
Time frame: 14 days
repeatability and reproducibility
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 10 Jul 2019.
- Background: PubMed 25711274Neglia D, Rovai D, Caselli C, Pietila M, Teresinska A, Aguade-Bruix S, Pizzi MN, Todiere G, Gimelli A, Schroeder S, Drosch T, Poddighe R, Casolo G, Anagnostopoulos C, Pugliese F, Rouzet F, Le Guludec D, Cappelli F, Valente S, Gensini GF, Zawaideh C, Capitanio S, Sambuceti G, Marsico F, Perrone Filardi P, Fernandez-Golfin C, Rincon LM, Graner FP, de Graaf MA, Fiechter M, Stehli J, Gaemperli O, Reyes E, Nkomo S, Maki M, Lorenzoni V, Turchetti G, Carpeggiani C, Marinelli M, Puzzuoli S, Mangione M, Marcheschi P, Mariani F, Giannessi D, Nekolla S, Lombardi M, Sicari R, Scholte AJ, Zamorano JL, Kaufmann PA, Underwood SR, Knuuti J; EVINCI Study Investigators. Detection of significant coronary artery disease by noninvasive anatomical and functional imaging. Circ Cardiovasc Imaging. 2015 Mar;8(3):e002179. doi: 10.1161/CIRCIMAGING.114.002179.
- Individual participant dataSharing planned: No. WILL NOT BE SHARED
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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
3 sites 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 AUM Cardiovascular, Inc. at 3 sites 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 23 inclusion and 25 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Positive Percent Agreement and Negative Percent Agreement (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03793049, which also lists 1 linked publication.
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 10 Jul 2019.