Clinical Evaluation of the CADence Device in Detection of Coronary Artery Diseases (TURBULENCE)
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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 |
- 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 |
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.
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:
- 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
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| 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 | |
| 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