Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease (NT-pro-MICI)

July 13, 2020 updated by: Centre Hospitalier Universitaire, Amiens

NT-proBNP is a major diagnostic and prognostic marker in cardiology, but it is also a new marker for biological inflammation, especially in rheumatology.

Its evaluation in chronic inflammatory bowel disease was carried out in a preliminary study, the OPERA study where in a population of 12 patients showed an increase in NT-proBNP correlated with the biological and endoscopic activity of the disease. This larger study is therefore a pilot study that could see NTproBNP as a new biomarker of inflammation in MICI.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80054
        • CHU Amiens Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult subjects (age 18 years)
  • MICI Group: Patients monitored for probable HC or MC
  • Control group: Patients referred for consultation in gastroenterology with a clinical and endoscopic picture eading to the diagnosis of TF I
  • Person who agreed to participate in the study
  • Patient covered by social insurance

Exclusion Criteria:

  • Causes of increased concentrations of natriuretic peptides: acute heart failure, acute or chronic pulmonary disease with right ventricular repercussion, valvulopathies, primary or secondary HVG, atrial fibrillation cardiac arrhythmia, chronic systolic dysfunction, hyperthyroidism, Addison's disease, hyperaldosteronism Primary, diabetes, cirrhosis with ascites, cancers, chronic renal insufficiency.
  • Inflammatory and autoimmune diseases (excluding MC and RCH), chronic inflammatory syndrome
  • Ongoing treatment that may affect the concentration of natriuretic peptides: ACE inhibitor, angiotensin II receptor antagonists, diuretics
  • Patient deprived of liberty or protected major (under guardianship or curatorship)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with CD or RCH
Other: Evaluate the blood level of NTproBNP
Evaluate the blood level of NTproBNP in patients with MICI compared to a healthy control population.
Other: The control population
Other: Evaluate the blood level of NTproBNP
Evaluate the blood level of NTproBNP in patients with MICI compared to a healthy control population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood level of NTproBNP.
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2013

Primary Completion (Actual)

August 7, 2017

Study Completion (Actual)

August 7, 2017

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2013_843_0015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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