- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01476995
Prognostic Indicators as Provided by the EPIC ClearView (GBMC)
Study Overview
Status
Conditions
- Coronary Artery Disease
- Pneumonia
- Hypertension
- Diabetes
- Irritable Bowel Syndrome
- Atrial Fibrillation
- Asthma
- Renal Failure
- Emphysema
- Cholecystitis
- Cirrhosis
- Crohn's Disease
- Ulcerative Colitis
- Acute Renal Failure
- Diverticulitis
- Pancreatitis
- Bronchitis
- Valvular Heart Disease
- Inflammatory Bowel Disease
- COPD
- Congestive Heart Failure
- Pyelonephritis
- Steatohepatitis
- Alcoholic Hepatitis
- Peptic Ulcer Disease
- Viral Hepatitis
- Celiac Sprue
- Malabsorption Disorders
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21204
- Greater Baltimore Medical Cente
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Five Diagnosis Group:
- Sex: Male or Female
- Age range: 18 to 85
Qualifying medical diagnoses (5 diagnosis groups)
- For potential subjects presenting with one of the five qualifying diagnoses, the patient presents with confirmed active medical diagnoses affecting the following systems or organs:
- Cardiovascular system: coronary artery disease, left sided congestive heart failure with EF <50%, valvular heart disease, atrial fibrillation, and hypertension
- Kidney: pyelonephritis, acute renal failure, or chronic renal failure stages II-V
- Liver: viral hepatitis, alcoholic hepatitis, steatohepatitis, or cirrhosis
- Pulmonary system: asthma, COPD, bronchitis, emphysema, or pneumonia
- Gastrointestinal/Endocrine: inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or diverticulitis), peptic ulcer disease, IBS, cholecystitis, pancreatitis, or malabsorption disorders (including Celiac Sprue); diabetes (Type 1 and Type 2)
- The patient or legal representative is able to understand and provide signed consent for the procedure.
- Every effort will be given to balance subjects by gender, age, and race. At least 60 subjects from each of the 5 diagnostic groups and the 1 control group will be recruited.
Control Group:
- Sex: Male or Female
- Age range: 18 to 85
Freedom from qualifying medical diagnoses (control group)
- For potential subjects for the control group, the subject is free from active medical diagnoses affecting the following systems or organs:
- Cardiovascular system: coronary artery disease, left sided congestive heart failure with EF <50%, valvular heart disease, atrial fibrillation, and hypertension
- Kidney: pyelonephritis, acute renal failure, or chronic renal failure stages II-V
- Liver: viral hepatitis, alcoholic hepatitis, steatohepatitis, or cirrhosis
- Pulmonary system: asthma, COPD, bronchitis, emphysema, or pneumonia
- Gastrointestinal/Endocrine: inflammatory bowel disease (including Crohn's disease, ulcerative colitis, or diverticulitis), peptic ulcer disease, IBS, cholecystitis, pancreatitis, or malabsorption disorders (including Celiac Sprue); diabetes (type 1 and type 2)
- The patient or legal representative is able to understand and provide signed consent for the procedure.
- Every effort will be given to balance subjects by gender, age, and race. At least 60 subjects from each of the 5 diagnostic groups and the 1 control group will be recruited.
Exclusion Criteria:
- Patients < 18 years in age or > 85 years in age.
- Inability or unwillingness to provide informed consent.
- Patients with pacemakers or another electrical device implanted somewhere in their body.
- Pregnant women.
- Patients currently undergoing therapy for cancer of any kind.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Controls
Men and women ages 18-85 lacking any medical diagnosis (as defined in the protocol) of one or more of the following systems/organs: cardiovascular system; gastrointestinal system; kidneys; liver; lungs.
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Five Diagnosis Group
Men and women ages 18-85 with at least one active medical diagnosis (as defined in the protocol) of one or more of the following systems/organs: cardiovascular system; gastrointestinal system; kidneys; liver; lungs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agreement of ClearView Scan versus Active Diagnosis
Time Frame: At time of ClearView Scan (Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit).
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Statistical agreement will be assessed between the 0-25 ClearView Response Scale and the physician's diagnoses recorded within the medical record, on a per-subject basis.
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At time of ClearView Scan (Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and Specificity of ClearView Scan versus Active Diagnosis
Time Frame: Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit.
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Sensitivity and Specificity of the ClearView Scan relative to an active diagnosis, as the proportion of subjects with correctly captured findings amongst those with an active diagnosis and the proportion of subjects without a ClearView finding amongst those without an active diagnosis, respectively.
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Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit.
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Collaborators and Investigators
Investigators
- Principal Investigator: Clair A Francomano, MD, Greater Baltimore Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Digestive System Diseases
- Pathologic Processes
- Myocardial Ischemia
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Alcohol-Related Disorders
- Substance-Related Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Lung Diseases
- Kidney Diseases
- Urologic Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Liver Diseases
- Bronchial Diseases
- Gastroenteritis
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Arrhythmias, Cardiac
- Lung Diseases, Obstructive
- Coronary Disease
- Duodenal Diseases
- Malabsorption Syndromes
- Gallbladder Diseases
- Biliary Tract Diseases
- Pancreatic Diseases
- Nephritis
- Diverticular Diseases
- Nephritis, Interstitial
- Pyelitis
- Liver Diseases, Alcoholic
- Alcohol-Induced Disorders
- Heart Failure
- Heart Diseases
- Coronary Artery Disease
- Irritable Bowel Syndrome
- Hepatitis
- Inflammatory Bowel Diseases
- Hepatitis A
- Fatty Liver
- Atrial Fibrillation
- Emphysema
- Renal Insufficiency
- Celiac Disease
- Cholecystitis
- Crohn Disease
- Acute Kidney Injury
- Diverticulitis
- Pancreatitis
- Heart Valve Diseases
- Bronchitis
- Pyelonephritis
- Peptic Ulcer
- Hepatitis, Alcoholic
Other Study ID Numbers
- GBMC Triage Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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