Rheumatoid Arthritis
Conditions
Keywords
rheumatoid arthritis, inflammation
Brief summary
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.
Detailed description
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.
Interventions
OTHERcardiac Magnetic Resonance imaging
Sponsors
Arthritis Foundation
Vanderbilt University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Individuals specialized in cMRI performed the analyses and were blinded to disease status of participants.
Intervention model description
All participants underwent cardiac MRI(cMRI) using a 1.5 tesla Siemens Magnetom Avanto scanner to compare left ventricular structure and Left atrium size.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent * Age \>= 18 * RA only: meet American College of Rheumatology(ACR)criteria for Diagnosis of RA * Controls only: no evidence of RA or other inflammatory disease
Exclusion criteria
* Previous or current heart failure or ischemic cardiovascular disease (eg stroke, myocardial infarction, angina, CABG, stent). * Atrial fibrillation. * Known structural or functional cardiac abnormality, including pulmonary htn. * Glomerular filtration rate \< 60 ml/min. * Pregnancy or breastfeeding. * Unable to perform MRI (claustrophobia, unable to fit in magnet,pacemaker,defibrillator or non-MR safe implant). * Hypersensitivity to gadolinium.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Mass Indexed to BSA, g/m^2 | one scan, cross sectional comparison | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Atrium Size, mm | one scan, cross sectional comparison | left atrium size, measured in millimeters |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Rheumatoid Arthritis Patients People who have rheumatoid arthritis | 59 |
| Controls people who do not have RA or other inflammatory disease | 56 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | claustrophobic when entering cardiac MRI | 2 | 1 |
| Overall Study | EGFR <60ml/min | 6 | 4 |
Baseline characteristics
| Characteristic | Rheumatoid Arthritis Patients | Total | Controls |
|---|---|---|---|
| Age, Continuous | 53 years | 53 years | 52 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 58 Participants | 113 Participants | 55 Participants |
| Region of Enrollment United States | 59 participants | 115 participants | 56 participants |
| Sex: Female, Male Female | 45 Participants | 89 Participants | 44 Participants |
| Sex: Female, Male Male | 14 Participants | 26 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 61 |
| other Total, other adverse events | 0 / 67 | 0 / 61 |
| serious Total, serious adverse events | 0 / 67 | 0 / 61 |
Outcome results
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).
Time frame: one scan, cross sectional comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rheumatoid Arthritis Patients | Left Ventricular Mass Indexed to BSA, g/m^2 | 43.8 g/m^2 |
| Controls | Left Ventricular Mass Indexed to BSA, g/m^2 | 42.2 g/m^2 |
Secondary
Left Atrium Size, mm
left atrium size, measured in millimeters
Time frame: one scan, cross sectional comparison
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rheumatoid Arthritis Patients | Left Atrium Size, mm | 29 mm |
| Controls | Left Atrium Size, mm | 29 mm |