Study Stopped
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Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease
NT-pro-MICI
1 other identifier
interventional
159
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 28, 2013
CompletedFirst Submitted
Initial submission to the registry
April 5, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2017
CompletedJuly 15, 2020
July 1, 2020
3.8 years
April 5, 2017
July 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Blood level of NTproBNP.
1 month
Study Arms (2)
Patients with CD or RCH
OTHERThe control population
OTHERInterventions
Evaluate the blood level of NTproBNP in patients with MICI compared to a healthy control population.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens Picardie
Amiens, Picardie, 80054, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2017
First Posted
April 11, 2017
Study Start
October 28, 2013
Primary Completion
August 7, 2017
Study Completion
August 7, 2017
Last Updated
July 15, 2020
Record last verified: 2020-07