Myocardial InflammationNCT03776682
Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study
An observational study of Myocardial Inflammation and Rheumatoid Arthritis, run by Mayo Clinic at 1 site in United States.
Trial summary
Rheumatoid arthritis (RA) patients have a higher prevalence of subclinical atherosclerosis than the general population. In addition, RA patients experience higher rates of heart failure with preserved ejection fraction (HFpEF). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Myocardial Inflammation, Rheumatoid Arthritis, Coronary Artery Disease
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2018to 26 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of 40 Patients with the diagnosis of RA, according to 2010 ACR classification, who are referred to the Mayo Clinic Department of Rheumatology outpatient clinic.
Who may be able to join
- Diagnosis of Rheumatoid Arthritis according to 2010 American College of Rheumatology (ACR) criteria (14)
- RA disease duration ≤ 10 years since diagnosis
- Able to provide informed consent
Who cannot join
- Known clinical atherosclerotic disease (myocardial infarction, severe obstruction CAD (≥ 1 untreated stenosis (≥ 70% in a major vessel) known by either invasive or noninvasive testing), prior coronary artery intervention, prior coronary artery bypass surgery, cerebrovascular event, peripheral vascular disease).
- Prednisone >10mg per day (or equivalent corticosteroid dose per day within last week)
- Irregular heart rhythm (arrhythmia or cardiac conduction abnormality (e.g. atrial fibrillation or flutter, frequent extrasystole, LBBB)
- Relevant valvular heart disease (> moderate regurgitation or stenosis of any heart valve)
- Clinical occurrence of heart failure with or without preserved ejection fraction
- Impaired imaging quality or other contraindications for myocardial strain imaging
Show all 21Show fewer
- Relevant lung disease (including severe COPD with oxygen dependence, fibrosis, symptomatic pleural effusion, oxygen dependence)
- Sarcoidosis
- Diabetes mellitus treated with insulin
- estimated glomerular filtration rate (eGFR) < 40ml/min
- Known cancer
- History of any-type of cardiomyopathy (e.g. cardiac amyloidosis, hypertrophic cardiomyopathy,...)
- Ejection fraction (EF) less than 45%
- Life expectancy < 1 year
- BMI >40kg/m2
- Severe claustrophobia
- Any known allergic reactions to intravenous contrast
- Inability to receive beta blocker therapy or IV nitrates
- Pregnant/ Breastfeeding women
- Vulnerable persons due to Helsinki Declaration
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Rheumatoid arthritis (RA) patients have a higher prevalence of subclinical atherosclerosis than the general population. In addition, RA patients experience higher rates of heart failure with preserved ejection fraction (HFpEF). There is evidence that myocardial mechanics and left ventricular diastolic function are more abnormal in the RA population and these changes occur earlier than in the general population. Recently a study suggested that RA patient have abnormal myocardial inflammation during a disease flare and that this is improved with anti-inflammatory treatment. This study is aimed at describing the prevalence of myocardial inflammation in patients during active RA disease flares and comparing that with RA patients who are in remission. Investigators hope to show that abnormalities in myocardial inflammation on PET imaging correlate with abnormalities in myocardial strain on echocardiography. Coronary CT will be performed to establish the presence of subclinical atherosclerosis and whether its presence affects changes in either myocardial inflammation or myocardial strain. The hypothesis is that patients with evidence of myocardial inflammation during the course of their RA disease are more likely to develop HFpEF during their lifetime. Although the present study will not be of a duration to assess outcome, it will provide descriptive data which may help guide future prospective study of patients with RA which may help guide appropriate cardiovascular testing in this high risk population.
- Medical subject headings
- Myocarditis, Arthritis, Rheumatoid, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute inflammation | Patients with RA and active inflammation (by exam or inflammatory markers) | |
| Chronic remission | Patients with RA who are in remission (clinically) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subclinical myocardial inflammatory burden as detected by PET imaging
To determine if myocardial F-18 fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging in patients with rheumatoid arthritis reveals evidence of subclinical myocardial inflammation which correlate with level of systemic inflammatory burden.
Measured: 14 days
Relationship of presence of myocardial inflammation to atherosclerotic burden
To determine if mild to moderate atherosclerotic plaque burden on coronary computed tomographic angiography (CCTA) correlates with the degree of myocardial inflammation as assessed by FDG PET.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start22 Jun 2018
- Primary completion26 May 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InflammationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rekha Mankad, Mayo Clinic
- Investigators
- Rekha Mankad, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776682
- Sponsor's protocol ID
- 17-009867
- Status last verified
- Jul 2023
- First submitted
- 11 Dec 2018
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study
- ClinicalTrials.gov ID
- NCT03776682
- Acronym / sponsor ID
- 17-009867
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rheumatoid arthritis (RA) patients have a higher prevalence of subclinical atherosclerosis than the general population. In addition, RA patients experience higher rates of heart failure with preserved ejection fraction (HFpEF). There is evidence that myocardial mechanics and left ventricular diastolic function are more abnormal in the RA population and these changes occur earlier than in the general population. Recently a study suggested that RA patient have abnormal myocardial inflammation during a disease flare and that this is improved with anti-inflammatory treatment. This study is aimed at describing the prevalence of myocardial inflammation in patients during active RA disease flares and comparing that with RA patients who are in remission. Investigators hope to show that abnormalities in myocardial inflammation on PET imaging correlate with abnormalities in myocardial strain on echocardiography. Coronary CT will be performed to establish the presence of subclinical atherosclerosis and whether its presence affects changes in either myocardial inflammation or myocardial strain. The hypothesis is that patients with evidence of myocardial inflammation during the course of their RA disease are more likely to develop HFpEF during their lifetime. Although the present study will not be of a duration to assess outcome, it will provide descriptive data which may help guide future prospective study of patients with RA which may help guide appropriate cardiovascular testing in this high risk population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute inflammation | – | –Patients with RA and active inflammation (by exam or inflammatory markers) |
| Chronic remission | – | –Patients with RA who are in remission (clinically) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 40 Patients with the diagnosis of RA, according to 2010 ACR classification, who are referred to the Mayo Clinic Department of Rheumatology outpatient clinic.
Key inclusion criteria (3 listed)
- Diagnosis of Rheumatoid Arthritis according to 2010 American College of Rheumatology (ACR) criteria (14)
- RA disease duration ≤ 10 years since diagnosis
- Able to provide informed consent
Key exclusion criteria (21 listed)
- Known clinical atherosclerotic disease (myocardial infarction, severe obstruction CAD (≥ 1 untreated stenosis (≥ 70% in a major vessel) known by either invasive or noninvasive testing), prior coronary artery intervention, prior coronary artery bypass surgery, cerebrovascular event, peripheral vascular disease).
- Prednisone >10mg per day (or equivalent corticosteroid dose per day within last week)
- Irregular heart rhythm (arrhythmia or cardiac conduction abnormality (e.g. atrial fibrillation or flutter, frequent extrasystole, LBBB)
- Relevant valvular heart disease (> moderate regurgitation or stenosis of any heart valve)
- Clinical occurrence of heart failure with or without preserved ejection fraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subclinical myocardial inflammatory burden as detected by PET imaging
Time frame: 14 days
To determine if myocardial F-18 fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging in patients with rheumatoid arthritis reveals evidence of subclinical myocardial inflammation which correlate with level of systemic inflammatory burden.
Relationship of presence of myocardial inflammation to atherosclerotic burden
Time frame: 7 days
To determine if mild to moderate atherosclerotic plaque burden on coronary computed tomographic angiography (CCTA) correlates with the degree of myocardial inflammation as assessed by FDG PET.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rekha Mankad, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Inflammation and Rheumatoid Arthritis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subclinical myocardial inflammatory burden as detected by PET imaging (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.