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

This study is currently recruiting participants.
Verified April 2013 by AUM Cardiovascular, Inc.
Sponsor:
Information provided by (Responsible Party):
AUM Cardiovascular, Inc.
ClinicalTrials.gov Identifier:
NCT01743040
First received: December 4, 2012
Last updated: April 1, 2013
Last verified: April 2013
  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 in a subject is defined as the presence of a 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.


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: 456
Study Start Date: February 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (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 >35

Known coronary disease as defined as:

prior angiogram with significant coronary disease in one of the major coronary arteries.

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 The 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<60 (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, Iowa
Iowa Heart Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Teresa Coulson, RN     515-633-3840     tcoulson@iowaheart.com    
Principal Investigator: Mark Tannebaum, MD            
United States, Minnesota
Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Shelly Bloch, MS, RN     763-236-9168     betty.hargan@metrocardiology.com    
Principal Investigator: Jeffrey Chambers, MD            
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Robert Wilson, MD     612-910-8651     rwilson430@gmail.com    
Contact: Emily Caldwell, RN     612-624-7178     caldw076@gmail.com    
Principal Investigator: Robert Wilson, MD            
Abbott/Minneapolis Heart Institute Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: JoAnne Goldman, RT     612-863-3793     JoAnne.Goldman@allina.com    
Principal Investigator: Robert Schwartz, MD            
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Traci Hammer, CCRP     507-255-2649     olson.monica2@mayo.edu    
Principal Investigator: Abhiram Prasad, MD            
United States, New York
Columbia University Not yet recruiting
New York City, New York, United States, 10032
Contact: Magnolia Jimenez     212-305-4275     mj2377@columbia.edu    
Principal Investigator: Sabahat Bokhari, MD            
Mt. Sinai Recruiting
New York City, New York, United States
Contact: Milena Henzlova, MD         milena.henzlova@mountsinai.org    
Contact: Christine Seidler, RN         christine.seidler@mountsinai.org    
Principal Investigator: Milena Henzlova, MD            
Sponsors and Collaborators
AUM Cardiovascular, Inc.
Investigators
Study Chair: Robert Wilson, MD University of Minnesota - Clinical and Translational Science Institute
  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: April 1, 2013
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 May 16, 2013