Primary Biliary CholangitisEARLY-MYO-PBCNCT03545672
Early Identification of Myocardial Impairment in PBC
An observational study of Primary Biliary Cholangitis and Cardiovascular Abnormalities, run by RenJi Hospital at 1 site in China.
Trial summary
Primary biliary cholangitis (PBC) is a chronic inflammatory liver disease leading to cirrhosis. Researches reported patients with PBC may involve abnormalities on skeleton, thyroid and exocrine glands. However, whether this autoimmune disease would cause cardiac impairment is scarcely investigated. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Biliary Cholangitis, Cardiovascular Abnormalities
- What is being tested?
- CMR examination
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2017to 1 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive subjects from three centers were prospectively enrolled into 2 cohorts between September 2017 and April 2019. The cohorts were divided as follows: the PBC patients group and the control group.
Who may be able to join
- Age between 18-80 years old.
- Definite primary biliary cirrhosis diagnosis which is consistent with European Association for the Study of the Liver (EASL) [Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis (2017)]. The following three diagnostic factors, at least meet two:
- History of elevated alkaline phosphatase (ALP) levels;
- Liver biopsy consistent with PBC;
- Positive antimitochondrial antibodies (AMA) or specific antinuclear antibodies;
- Providing written informed consent
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- Absence of known systemic diseases
- Normal examinations in CMR/Echo/ECG
- Age between 18-80 years old.
- Providing written informed consent
Who cannot join
- History or presence of other concomitant liver disease including:
- cirrhosis or viral hepatitis;
- Inherited metabolic liver disease;
- Drug-induced liver injury;
- Other systemic disease inducing liver change.
- Subjects with life expectancy < 6 months.
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- Subjects with known ischemic/non-ischemic cardiomyopathy or abnormal in cardiac-related examinations.
- Subjects with standard metallic contraindications to CMR (i.e., estimated glomerular filtration rate < 30 ml/min/1.73 m2, New York Heart Association functional capacity class IV)
- Subjects with known heart disease including:
- Documented coronary artery disease;
- Ischemia/non-ischemia cardiomyopathy;
- Other systemic disease inducing heart change.
- Subjects with known liver disease including:
- Viral hepatitis;
- Inherited metabolic liver disease;
- Drug-induced liver injury;
- Other systemic disease inducing liver change.
- Subjects with standard metallic contraindications to CMR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EARLY Identification of MYOcardial Impairment in Primary Biliary Cholangitis
Primary biliary cholangitis (PBC) is a chronic inflammatory liver disease leading to cirrhosis. Researches reported patients with PBC may involve abnormalities on skeleton, thyroid and exocrine glands. However, whether this autoimmune disease would cause cardiac impairment is scarcely investigated. Cardiovascular Magnetic Resonance(CMR) is recently developed as a reliable modality to evaluate the cardiac tissue characteristics and functions. This study aims to investigate the cardiac status in PBC patients based on CMR.
Read the detailed description
Primary biliary cholangitis (PBC) is a progressive and uncommon inflammatory autoimmune cholesteric liver disease，which will contribute to cirrhosis. Symptoms and course of primary biliary cholangitis can be diverse, wherefore the targets of the current treatment are focused on the prevention of end-stage liver disease. Researches reported patients with PBC may involve abnormalities on skeleton, thyroid and exocrine glands. However, whether this autoimmune disease would cause cardiac impairment is scarcely investigated. From our clinical practice, the cardiac structural abnormal can be found in certain patients with PBC detected by cardiovascular magnet resonance (CMR). CMR is the primary and emerging imaging modality for myocardial tissue characterization, and it is recommended as a gold standard for functional imaging and assessment. This three-center, multi-modality, prospective observational study plans to identify the type and the severity of cardiac changes in PBC.
- Being tested
- CMR examination
- Keywords
- Primary Biliary Cholangitis, Cardiac impairment, Cardiovascular Magnetic Resonance
- Medical subject headings
- Liver Cirrhosis, Biliary, Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMR examinationDiagnostic test
After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
| Study group | Role | What they receive |
|---|---|---|
| PBC group | Patients have a definite PBC diagnosis. Receives: Diagnostic Test: CMR examination | |
| Control group | The healthy volunteers. Receives: Diagnostic Test: CMR examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Cardiac Events
All PBC patients are followed up through telephone or by retrieving outpatient medical record systems. Cardiac events include: 1. cardiac death; 2. myocardial infarction; 3. hospitalization for unstable angina.
Measured: 7 months after first CMR scanning
Quantitative Assessment in Cardiac Injury
T1 mapping-derived extracellular volumes (ECV) were used to detect changes in the myocardium interstitial matrix. ECV was calculated according to the ECV formula consist of T1 mapping value.
Measured: within 2 days of CMR scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start23 Oct 2017
- Primary completion15 Aug 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng Jiang, MD, Study chair, RenJi Hospital, School of Medicine, Shanghai Jiantong UniversityXiong Ma, MD,PhD, Study chair, RenJi Hospital, School of Medicine, Shanghai Jiantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545672
- Sponsor's protocol ID
- 201709P
- Acronym
- EARLY-MYO-PBC
- Status last verified
- Mar 2024
- First submitted
- 1 Feb 2018
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang P, Feng Z, Sheng L, Hu C, Ma X, Zhang S, Wu L, Xiao X, Wang Q, Guo C, Qiu D, Fang J, Xu J, Gershwin ME, Jiang M, Ma X, Pu J. Morphological, Functional, and Tissue Characterization of Silent Myocardial Involvement in Patients With Primary Biliary Cholangitis. Clin Gastroenterol Hepatol. 2022 May;20(5):1112-1121.e4. doi: 10.1016/j.cgh.2021.08.035. Epub 2021 Aug 28.
PubMed 34461299
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY Identification of MYOcardial Impairment in Primary Biliary Cholangitis
- ClinicalTrials.gov ID
- NCT03545672
- Acronym / sponsor ID
- EARLY-MYO-PBC / 201709P
- Keywords
- Primary Biliary Cholangitis, Cardiac impairment, Cardiovascular Magnetic Resonance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary biliary cholangitis (PBC) is a chronic inflammatory liver disease leading to cirrhosis. Researches reported patients with PBC may involve abnormalities on skeleton, thyroid and exocrine glands. However, whether this autoimmune disease would cause cardiac impairment is scarcely investigated. Cardiovascular Magnetic Resonance(CMR) is recently developed as a reliable modality to evaluate the cardiac tissue characteristics and functions. This study aims to investigate the cardiac status in PBC patients based on CMR.
Detailed description
Primary biliary cholangitis (PBC) is a progressive and uncommon inflammatory autoimmune cholesteric liver disease，which will contribute to cirrhosis. Symptoms and course of primary biliary cholangitis can be diverse, wherefore the targets of the current treatment are focused on the prevention of end-stage liver disease. Researches reported patients with PBC may involve abnormalities on skeleton, thyroid and exocrine glands. However, whether this autoimmune disease would cause cardiac impairment is scarcely investigated. From our clinical practice, the cardiac structural abnormal can be found in certain patients with PBC detected by cardiovascular magnet resonance (CMR). CMR is the primary and emerging imaging modality for myocardial tissue characterization, and it is recommended as a gold standard for functional imaging and assessment. This three-center, multi-modality, prospective observational study plans to identify the type and the severity of cardiac changes in PBC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBC group | – | Diagnostic Test: CMR examinationPatients have a definite PBC diagnosis. |
| Control group | – | Diagnostic Test: CMR examinationThe healthy volunteers. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive subjects from three centers were prospectively enrolled into 2 cohorts between September 2017 and April 2019. The cohorts were divided as follows: the PBC patients group and the control group.
Key inclusion criteria (10 listed)
- Age between 18-80 years old.
- Definite primary biliary cirrhosis diagnosis which is consistent with European Association for the Study of the Liver (EASL) [Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis (2017)]. The following three diagnostic factors, at least meet two:
- Providing written informed consent
- Absence of known systemic diseases
- Normal examinations in CMR/Echo/ECG
Key exclusion criteria (18 listed)
- History or presence of other concomitant liver disease including:
- Subjects with life expectancy < 6 months.
- Subjects with known ischemic/non-ischemic cardiomyopathy or abnormal in cardiac-related examinations.
- Subjects with standard metallic contraindications to CMR (i.e., estimated glomerular filtration rate < 30 ml/min/1.73 m2, New York Heart Association functional capacity class IV)
- Subjects with known heart disease including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMR examinationAfter recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment. | Diagnostic test | Control group, PBC group |
Primary outcome
The Incidence of Cardiac Events
Time frame: 7 months after first CMR scanning
All PBC patients are followed up through telephone or by retrieving outpatient medical record systems. Cardiac events include: 1. cardiac death; 2. myocardial infarction; 3. hospitalization for unstable angina.
Quantitative Assessment in Cardiac Injury
Time frame: within 2 days of CMR scan
T1 mapping-derived extracellular volumes (ECV) were used to detect changes in the myocardium interstitial matrix. ECV was calculated according to the ECV formula consist of T1 mapping value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34461299Jiang P, Feng Z, Sheng L, Hu C, Ma X, Zhang S, Wu L, Xiao X, Wang Q, Guo C, Qiu D, Fang J, Xu J, Gershwin ME, Jiang M, Ma X, Pu J. Morphological, Functional, and Tissue Characterization of Silent Myocardial Involvement in Patients With Primary Biliary Cholangitis. Clin Gastroenterol Hepatol. 2022 May;20(5):1112-1121.e4. doi: 10.1016/j.cgh.2021.08.035. Epub 2021 Aug 28.
- 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.
Meng Jiang, MD study chair
RenJi Hospital, School of Medicine, Shanghai Jiantong University
Xiong Ma, MD,PhD study chair
RenJi Hospital, School of Medicine, Shanghai Jiantong University
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 Primary Biliary Cholangitis and Cardiovascular Abnormalities, run by RenJi Hospital at 1 site in China.
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 10 inclusion and 18 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 9 Aug 2024. 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 China. 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?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Incidence of Cardiac Events (time frame: 7 months after first CMR scanning). 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?
On the ClinicalTrials.gov record for NCT03545672, which also lists 1 linked publication.
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 9 Aug 2024.