Trial Outcomes & Findings for Inflammation and the Heart (NCT NCT01589770)

Last Updated: 2019-05-06

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

128 participants

Primary outcome timeframe

one scan, cross sectional comparison

Results posted on

2019-05-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Rheumatoid Arthritis Patients People who have rheumatoid arthritis	Controls people who do not have RA or other inflammatory disease
Overall Study STARTED	67	61
Overall Study COMPLETED	59	56
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Rheumatoid Arthritis Patients People who have rheumatoid arthritis	Controls people who do not have RA or other inflammatory disease
Overall Study EGFR <60ml/min	6	4
Overall Study claustrophobic when entering cardiac MRI	2	1

Baseline Characteristics

Inflammation and the Heart

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rheumatoid Arthritis Patients n=59 Participants People who have rheumatoid arthritis	Controls n=56 Participants people who do not have RA or other inflammatory disease	Total n=115 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	52 years n=7 Participants	53 years n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	44 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants	55 Participants n=7 Participants	113 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants	56 participants n=7 Participants	115 participants n=5 Participants

PRIMARY outcome

Timeframe: one scan, cross sectional comparison

Outcome measures

Outcome measures
Measure	Rheumatoid Arthritis Patients n=59 Participants People who have rheumatoid arthritis	Controls n=56 Participants people who do not have RA or other inflammatory disease
Left Ventricular Mass Indexed to BSA, g/m^2	43.8 g/m^2 Interval 40.0 to 49.5	42.2 g/m^2 Interval 36.4 to 48.5

SECONDARY outcome

Timeframe: one scan, cross sectional comparison

left atrium size, measured in millimeters

Outcome measures

Outcome measures
Measure	Rheumatoid Arthritis Patients n=59 Participants People who have rheumatoid arthritis	Controls n=56 Participants people who do not have RA or other inflammatory disease
Left Atrium Size, mm	29 mm Interval 24.0 to 32.0	29 mm Interval 26.0 to 32.0

Adverse Events

Rheumatoid Arthritis Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. C. M. Stein

Vanderbilt University Medical Center

Phone: 615-936-3420

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place