Back to resultsInflammation and the Heart
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cardiac Magnetic Resonance imaging
Sponsored by
About this trial
This is an interventional other trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, inflammation
Eligibility Criteria
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.
Sites / Locations
- Vanderbilt
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
rheumatoid arthritis patients
controls
Arm Description
People who have rheumatoid arthritis underwent cMRI
people who do not have RA or other inflammatory disease underwent cMRI
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Left Atrium Size, mm
left atrium size, measured in millimeters
Full Information
NCT ID
NCT01589770
First Posted
April 24, 2012
Last Updated
April 23, 2019
Sponsor
Vanderbilt University
Collaborators
Arthritis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01589770
Brief Title
Inflammation and the Heart
Official Title
Inflammation and the Heart
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
Arthritis Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, inflammation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Individuals specialized in cMRI performed the analyses and were blinded to disease status of participants.
Allocation
Non-Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rheumatoid arthritis patients
Arm Type
Other
Arm Description
People who have rheumatoid arthritis underwent cMRI
Arm Title
controls
Arm Type
Other
Arm Description
people who do not have RA or other inflammatory disease underwent cMRI
Intervention Type
Other
Intervention Name(s)
cardiac Magnetic Resonance imaging
Primary Outcome Measure Information:
Title
Left Ventricular Mass Indexed to BSA, g/m^2
Description
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
Secondary Outcome Measure Information:
Title
Left Atrium Size, mm
Description
left atrium size, measured in millimeters
Time Frame
one scan, cross sectional comparison
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Michael Stein, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IDP that underlie results in a publication
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
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.
Citations:
PubMed Identifier
29657146
Citation
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.
Results Reference
result
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Inflammation and the Heart
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