Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Arthritis Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Studies have shown that people with rheumatoid arthritis (RA) have a higher rate of heart disease than people that do not have RA. we believe this is caused by the inflammation produced by RA.
Aim 1: We want to study people with RA to see if we can detect very early changes in their heart muscle and compare these results to people who do not have RA.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rheumatoid arthritis patients | Other | People who have rheumatoid arthritis underwent cMRI |
|
| controls | Other | people who do not have RA or other inflammatory disease underwent cMRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiac Magnetic Resonance imaging | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Mass Indexed to BSA, g/m^2 | Left Ventricular Mass (LVM) is known to increase in proportion to overall body size and differs by gender. To assess an individual's risk for a cardiovascular event based on LVM,an adjustment for the patient's body size should be done. LVM in grams was divided by body surface area in meters squared, to adjust for body size. Body surface area was calculated by square root (height (cm) X weight (kg)/3600). | one scan, cross sectional comparison |
| Measure | Description | Time Frame |
|---|---|---|
| Left Atrium Size, mm | left atrium size, measured in millimeters | one scan, cross sectional comparison |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles Michael Stein, MD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29657146 | Result | Bradham W, Ormseth MJ, Elumogo C, Palanisamy S, Liu CY, Lawson MA, Soslow JH, Kawel-Boehm N, Bluemke DA, Stein CM. Absence of Fibrosis and Inflammation by Cardiac Magnetic Resonance Imaging in Rheumatoid Arthritis Patients with Low to Moderate Disease Activity. J Rheumatol. 2018 Aug;45(8):1078-1084. doi: 10.3899/jrheum.170770. Epub 2018 Apr 15. |
Not provided
Not provided
all IDP that underlie results in a publication
Not provided
6 months after publication
IPD will be shared on request made to the PI. Criteria: Data is not to be shared. Data should only be used for biomedical research. Researchers requesting access will need appropriate IRB approval and sign a data use agreement.
Not provided
Not provided
Participants were recruited from the Vanderbilt Rheumatology practice, responses to advertisements, and word of mouth. Exclusion criteria included estimated glomerular filtration rate of <60 ml/min and inability to undergo cardiac MRI.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rheumatoid Arthritis Patients | People who have rheumatoid arthritis |
| FG001 | Controls | people who do not have RA or other inflammatory disease |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rheumatoid Arthritis Patients | People who have rheumatoid arthritis |
| BG001 | Controls | people who do not have RA or other inflammatory disease |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Left Ventricular Mass Indexed to BSA, g/m^2 | Left Ventricular Mass (LVM) is known to increase in proportion to overall body size and differs by gender. To assess an individual's risk for a cardiovascular event based on LVM,an adjustment for the patient's body size should be done. LVM in grams was divided by body surface area in meters squared, to adjust for body size. Body surface area was calculated by square root (height (cm) X weight (kg)/3600). | Posted | Median | Inter-Quartile Range | g/m^2 | one scan, cross sectional comparison |
|
Research study was done in one day. Adverse events were recorded for the day that research study took place.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rheumatoid Arthritis Patients | People who have rheumatoid arthritis | 0 |
Not provided
Not provided
Study is cross-sectional. Rheumatoid arthritis patients had low to moderate disease activity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. C. M. Stein | Vanderbilt University Medical Center | 615-936-3420 | michael.stein@vanderbilt.edu |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
All participants underwent cardiac MRI(cMRI) using a 1.5 tesla Siemens Magnetom Avanto scanner to compare left ventricular structure and Left atrium size.
Not provided
Not provided
Individuals specialized in cMRI performed the analyses and were blinded to disease status of participants.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Left Atrium Size, mm | left atrium size, measured in millimeters | Posted | Median | Inter-Quartile Range | mm | one scan, cross sectional comparison |
|
|
|
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | Controls | people who do not have RA or other inflammatory disease | 0 | 61 | 0 | 61 | 0 | 61 |
Not provided
Not provided
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |