Clinical Evaluation of the CADence Device in Detection of Coronary Artery Diseases
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-000655
NCT ID: NCT01743040
Sponsor Protocol Number: 1038-001
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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 >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 of 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Patricia Best, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available