Clinical Evaluation of the CADence Device in Detection of Coronary Artery Diseases (TURBULENCE)

This study is currently recruiting participants.
Verified February 2014 by AUM Cardiovascular, Inc.
Sponsor:
Information provided by (Responsible Party):
AUM Cardiovascular, Inc.
ClinicalTrials.gov Identifier:
NCT01743040
First received: December 4, 2012
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

This is a multi-center, prospective, non-randomized, double-blinded trial to evaluate the performance of the CADence device in detecting the existence of clinically significant coronary artery disease.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pivotal Study of the CADence Device in Detection of Coronary Artery Diseases

Resource links provided by NLM:


Further study details as provided by AUM Cardiovascular, Inc.:

Primary Outcome Measures:
  • Non-inferiority [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Primary endpoints are sensitivity and specificity of the CADence in detecting at least one lesion with ≥70% diameter stenosis anywhere in the pLAD, mLAD pLCx, mLCx, pRCA, mRCA, dRCA and OM1, OM2, and RI if segment diameter >2.5 mm or ≥50% diameter stenosis in the LMAIN coronary arteries.


Estimated Enrollment: 729
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All enrolled subjects that received nuclear stress testing and either CT or standard coronary angiography after the CADence evaluation will be included in the analysis.

Criteria

Subjects clinically indicated for nuclear stress test and who satisfy all the inclusion and exclusion criteria are eligible for participation.

Inclusion criteria:

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:

  1. Dyslipidemia: LDL >130 mm/dL or HDL <35 mm/dL or on treatment for dyslipidemia
  2. Hypertension: blood pressure >140 mmHg systolic, >90 mmHg diastolic or on blood pressure altering treatment
  3. Obesity: BMI>28
  4. Current cigarette smoking
  5. Diabetes: Type 1 or 2
  6. Family history: coronary disease in a first or second degree relative

Exclusion criteria:

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 Presence of artificial valve Presence of obvious cyanotic or pre-diagnosed congenital heart defect and coarctation of the aorta Presence murmurs including valve lesions, ventricular septal defects, and AV fistualae.

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) Contraindication to CT angiography

  • Renal failure with GFR<50 (angio risk)
  • Iodinated contrast allergy
  • Elevated heart rate which cannot be controlled sufficiently to achieve a good CT angiogram
  • Body weight >350lbs.
  • Sinus rhythm rate greater than 100 beats per minute at screening.
  • Atrial fibrillation with average heart rate of greater than 70 beats per minute on resting screening ECG.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743040

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States
Contact: Greg Wright       gwright@uab.edu   
Principal Investigator: Steven Lloyd, MD         
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90502
Contact: Fred Flores    310-222-4107    fflores@labiomed.org   
Principal Investigator: Jay Thomas, MD         
United States, Connecticut
Hartford Hospital Not yet recruiting
Hartford, Connecticut, United States
Contact: Deb Katten       Dkatten@harthosp.org   
Principal Investigator: Lane Duvall, MD         
United States, Iowa
Iowa Heart Center Suspended
Des Moines, Iowa, United States, 50314
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States
Contact: Margaret Fox, RN       MFOX2@hfhs.org   
Principal Investigator: Gerald Koenig, MD         
United States, Minnesota
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Shelly Bloch, MS, RN    763-236-9168    shelly.bloch@mhvi.com   
Principal Investigator: Jeffrey Chambers, MD         
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Emily Caldwell, RN    612-624-7178    caldw076@gmail.com   
Principal Investigator: Ganesh Raveendra, MD         
Abbott/Minneapolis Heart Institute Suspended
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jessica Bauman    507-255-2649    Bauman.Jessica@mayo.edu   
Principal Investigator: Patricia Best, MD         
CentraCare Heart & Vascular Center Recruiting
St. Cloud, Minnesota, United States, 56303
Contact: Peg Dahl, RN    320-251-2700    dahlp@centracare.com   
Contact: Jen Wipper    320-251-2700    WipperJ@centracare.com   
Principal Investigator: Thomas Dahle, MD         
United Heart and Vascular Clinic Recruiting
St. Paul, Minnesota, United States, 55102
Contact: Kari Thomas    651-241-2815    kari.thomas@allina.com   
Principal Investigator: Alan Bank, MD         
United States, New York
Columbia University Recruiting
New York City, New York, United States, 10032
Contact: Magnolia Jimenez    212-305-4275    mj2377@columbia.edu   
Contact: Diana Kim       ddk2133@columbia.edu   
Principal Investigator: Sabahat Bokhari, MD         
Mt. Sinai Recruiting
New York City, New York, United States, 10032
Contact: Christine Seidler, RN       christine.seidler@mountsinai.org   
Principal Investigator: Milena Henzlova, MD         
United States, Tennessee
Jackson Clinic Recruiting
Jackson, Tennessee, United States, 38301
Contact: Suzan Lasley    731-422-0307    slasley@jacksonclinic.com   
Principal Investigator: Abdul Rashid, MD         
Sponsors and Collaborators
AUM Cardiovascular, Inc.
Investigators
Study Chair: Jay Thomas, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: AUM Cardiovascular, Inc.
ClinicalTrials.gov Identifier: NCT01743040     History of Changes
Other Study ID Numbers: 1038-001
Study First Received: December 4, 2012
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by AUM Cardiovascular, Inc.:
Coronary Artery Disease
Nuclear Stress Test
CT Angiography
Angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014