- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05402462
Esophageal Motility Disorders in Patients With Non-cardiac Chest Pain at Assiut University Hospital
May 31, 2022 updated by: Esraa medhat Ahmed, Assiut University
to determine the prevalence and distribution of esophageal motility disorders in NCCP patients who presented after a negative cardiac evaluation and underwent esophageal manometry, esophageal pH monitoring
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Non-cardiac chest pain (NCCP) is defined as recurrent anginalike pain without evidence of cardiac disease [1].
NCCP is a common disorder and accounts for 14-33% of patient visits to gastroenterologists [2].
These patients frequently undergo testing for reflux and esophageal motility as gastroesophageal reflux disease (GERD) is seen in 50-60% and esophageal motility disorders in 15-18% of the patients [3,4].
Nutcracker esophagus was thought to be the classic manometric finding in NCCP [5] but other studies have reported ineffective esophageal motility (IEM) as the most common motility disorder in NCCP [6,7].
Furthermore, up to one-third of patients do not have any GERD or motility disorders and are labeled as functional chest pain [8].
Suggested causes in these patients include esophageal hypersensitivity [9], abnormal cerebral pain processing and psychological comorbidity [10].
The clinical predictors of abnormal esophageal function tests in NCCP have not been identified.
Identifying these factors would lead to limited use of testing in those with risk factors and faster institution of pain modulator therapy in patients who are most likely to have functional chest pain.
Study Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Esraa Medhat, resident doctor
- Phone Number: 01099071931
- Email: esraamedhat449@gmail.com
Study Contact Backup
- Name: Alaa Eldeen Abd Elmonem, professor
- Phone Number: 01112732730
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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
to determine the prevalence and distribution of esophageal motility disorders in NCCP patients who presented after a negative cardiac evaluation and underwent esophageal manometry, esophageal pH monitoring
Description
Inclusion Criteria:
- Age above 18 years
- Patients presented with non-cardiac chest pain
Exclusion Criteria:
- 1- age below 18. 2- cardiac chest pain patients
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Esophageal motility disorders in patients with non-cardiac chest pain at Assiut University hospital
Time Frame: one year
|
Determine esophageal motility disorder in patient with non cardiac chest pain using ECG ,cardiac enzymes and echocardiography , esophageal manometry and upper endoscopy
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fass R, Achem SR. Noncardiac chest pain: epidemiology, natural course and pathogenesis. J Neurogastroenterol Motil. 2011 Apr;17(2):110-23. doi: 10.5056/jnm.2011.17.2.110. Epub 2011 Apr 27.
- Yamasaki T, Fass R. Noncardiac chest pain: diagnosis and management. Curr Opin Gastroenterol. 2017 Jul;33(4):293-300. doi: 10.1097/MOG.0000000000000374.
- Coss-Adame E, Rao SS. A Review of Esophageal Chest Pain. Gastroenterol Hepatol (N Y). 2015 Nov;11(11):759-66.
- Fass R, Dickman R. Non-cardiac chest pain: an update. Neurogastroenterol Motil. 2006 Jun;18(6):408-17. doi: 10.1111/j.1365-2982.2006.00787.x.
- Katz PO, Dalton CB, Richter JE, Wu WC, Castell DO. Esophageal testing of patients with noncardiac chest pain or dysphagia. Results of three years' experience with 1161 patients. Ann Intern Med. 1987 Apr;106(4):593-7. doi: 10.7326/0003-4819-106-4-593.
- Ribolsi M, Balestrieri P, Biasutto D, Emerenziani S, Cicala M. Role of Mixed Reflux and Hypomotility with Delayed Reflux Clearance in Patients with Non-cardiac Chest Pain. J Neurogastroenterol Motil. 2016 Oct 30;22(4):606-612. doi: 10.5056/jnm15182.
- Barret M, Herregods TV, Oors JM, Smout AJ, Bredenoord AJ. Diagnostic yield of 24-hour esophageal manometry in non-cardiac chest pain. Neurogastroenterol Motil. 2016 Aug;28(8):1186-93. doi: 10.1111/nmo.12818. Epub 2016 Mar 27.
- Remes-Troche JM. How to Diagnose and Treat Functional Chest Pain. Curr Treat Options Gastroenterol. 2016 Dec;14(4):429-443. doi: 10.1007/s11938-016-0106-y.
- Farmer AD, Ruffle JK, Aziz Q. The Role of Esophageal Hypersensitivity in Functional Esophageal Disorders. J Clin Gastroenterol. 2017 Feb;51(2):91-99. doi: 10.1097/MCG.0000000000000757.
- Zhang L, Tu L, Chen J, Song J, Bai T, Xiang XL, Wang RY, Hou XH. Health-related quality of life in gastroesophageal reflux patients with noncardiac chest pain: Emphasis on the role of psychological distress. World J Gastroenterol. 2017 Jan 7;23(1):127-134. doi: 10.3748/wjg.v23.i1.127.
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 (Anticipated)
June 30, 2022
Primary Completion (Anticipated)
January 30, 2024
Study Completion (Anticipated)
April 30, 2024
Study Registration Dates
First Submitted
February 18, 2022
First Submitted That Met QC Criteria
May 31, 2022
First Posted (Actual)
June 2, 2022
Study Record Updates
Last Update Posted (Actual)
June 2, 2022
Last Update Submitted That Met QC Criteria
May 31, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Esophageal motility disorders
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.
Clinical Trials on Esophageal Motility Disorders
-
Universidad Nacional de ColombiaHospital San Rafael de FacatativáNot yet recruitingEsophageal Achalasia | Spastic Esophageal Motility DisordersColombia
-
Assiut UniversityNot yet recruiting
-
Baylor College of MedicineRecruitingEsophageal Motility Disorders | AchalasiaUnited States
-
Peking Union Medical College HospitalCompleted
-
Federal State Budgetary Scientific Institution...Russian Science Foundation; Group of companies EFKORecruitingIneffective Esophageal Motility | GERD (Gastroesophageal Reflux Disease)Russian Federation
-
University Hospital, MotolRecruitingGastro Esophageal RefluxCzechia
-
Northwestern UniversityThe California Medical Innovations Institute, Inc.RecruitingDysphagia | Ineffective Esophageal Motility | Achalasia, EsophagealUnited States
-
Asian Institute of Gastroenterology, IndiaNot yet recruiting
-
Chinese University of Hong KongAcademy tertiary center, IECED, Guayaquil, EcuadorRecruitingAchalasia | EGJ Outflow ObstructionHong Kong, Ecuador
-
Asian Institute of Gastroenterology, IndiaRecruitingTumor | Achalasia CardiaIndia
Clinical Trials on upper endoscopy
-
Technical University of MunichRotkreuzklinikum München gGmbH; Klinikum Freising; Klinikum Landshut-Achdorf; Städtisches... and other collaboratorsCompletedEndoscopic Diagnosis in EsophagusGermany
-
Unidade Local De Saúde Do Norte AlentejanoNOVA Medical School; Universidade Nova de LisboaCompletedGastric Cancer | HELICOBACTER PYLORI INFECTIONS | Intestinal Metaplasia of Gastric Mucosa | Atrophic Gastritis | Gastric (Stomach) Cancer | High Grade Intraepithelial NeoplasiaPortugal
-
Assiut UniversityNot yet recruitingUpper Gastrointestinal Bleeding (UGIB)
-
Sohag UniversityRecruitingHelicobacter Pylori InfectionEgypt
-
Sohag UniversityCompletedAll Patients With Upper GIT Symptoms and Underwent Upper EndoscopyEgypt
-
Assiut UniversityNot yet recruitingUpper Gastrointestinal Disorder
-
Chinese University of Hong KongRecruitingEsophageal Cancer | Microbial ColonizationHong Kong
-
Sohag UniversityNot yet recruitingUpper Gastrointestinal BleedingEgypt