Early Identification of Myocardial Impairment in PBC

NCT03545672 | Completed Results DMC

• 1 other identifier: 201709P
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Primary Biliary Cholangitis; Cardiovascular Abnormalities

Keywords

Primary Biliary Cholangitis; Cardiac impairment; Cardiovascular Magnetic Resonance

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  within 2 days of CMR scan

Study Arms (2)

PBC group

Patients have a definite PBC diagnosis.

Diagnostic Test: CMR examination

Control group

The healthy volunteers.

Diagnostic Test: CMR examination

Interventions

CMR examination DIAGNOSTIC_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.

Control group; PBC group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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)
• Absence of known systemic diseases
• Normal examinations in CMR/Echo/ECG
• Age between 18-80 years old.
• Providing written informed consent
• Subjects with known heart disease including:
• Documented coronary artery disease;
• Ischemia/non-ischemia cardiomyopathy;

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

• 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.

  PMID: 34461299 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Cardiovascular Abnormalities

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Meng Jiang
• Organization: Renji Hospital, Shanghai Jiaotong University School of Medicine

jiangmeng0919@163.com

+86 13788912766

Study Officials

• Meng Jiang, MD

  RenJi Hospital, School of Medicine, Shanghai Jiantong University

  STUDY CHAIR

• Xiong Ma, MD,PhD

  RenJi Hospital, School of Medicine, Shanghai Jiantong University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: June 4, 2018
• Study Start: October 23, 2017
• Primary Completion: August 15, 2019
• Study Completion: December 1, 2019
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)