Repeatability and Reproducibility of the CADence™System

NCT03793049 | Completed FDA Device

• 1 other identifier: 1030-002-03
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Coronary Artery Disease

Keywords

acoustic; ECG

Outcome Measures

Primary Outcomes (1)

• Positive Percent Agreement and Negative Percent Agreement

  repeatability and reproducibility

  14 days

Interventions

CADence testing will be performed DEVICE

CADence is a noninvasive, handheld device comprised of acoustic and ECG technology and software

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with chest pain and 2 or more coronary artery disease risk factors

You may not qualify if:

• 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
• Age 22 years or older
• Willing and able to give informed consent
• Clinical indication for nuclear stress test evaluation
• Chest pain syndrome

Sponsors & Collaborators

• AUM Cardiovascular, Inc.: lead

Study Sites (3)

910 Medical

Minneapolis, Minnesota, 55455, United States

Location

Northfield Urgent Care Clinic

Northfield, Minnesota, 55057, United States

Location

Pivot Point Medical

Northfield, Minnesota, 55057, United States

Location

Related Publications (1)

• 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.

  PMID: 25711274 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• ROBERT WILSON, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 4, 2019
• Study Start: January 23, 2019
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)