NCT05402462

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

June 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.6 years

First QC Date

February 18, 2022

Last Update Submit

May 31, 2022

Conditions

Esophageal Motility Disorders

Outcome Measures

Primary Outcomes (1)

  • Esophageal motility disorders in patients with non-cardiac chest pain at Assiut University hospital

    Determine esophageal motility disorder in patient with non cardiac chest pain using ECG ,cardiac enzymes and echocardiography , esophageal manometry and upper endoscopy

    one year

Interventions

upper endoscopyDIAGNOSTIC_TEST

detect esphageal motility disorder by upper endoscopy and esophageal manometry

Also known as: esophageal manometry

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Age above 18 years
  • Patients presented with non-cardiac chest pain

You may not qualify if:

  • age below 18. 2- cardiac chest pain patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 21602987RESULT

  • Yamasaki T, Fass R. Noncardiac chest pain: diagnosis and management. Curr Opin Gastroenterol. 2017 Jul;33(4):293-300. doi: 10.1097/MOG.0000000000000374.

    PMID: 28463855RESULT

  • Coss-Adame E, Rao SS. A Review of Esophageal Chest Pain. Gastroenterol Hepatol (N Y). 2015 Nov;11(11):759-66.

    PMID: 27134590RESULT

  • 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.

    PMID: 16700719RESULT

  • 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.

    PMID: 3826958RESULT

  • 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.

    PMID: 27095707RESULT

  • 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.

    PMID: 27018150RESULT

  • 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.

    PMID: 27709331RESULT

  • 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.

    PMID: 28005634RESULT

  • 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.

    PMID: 28104988RESULT

MeSH Terms

Conditions

Esophageal Motility Disorders

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Deglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Esraa Medhat, resident doctor

CONTACT

01099071931esraamedhat449@gmail.com

Alaa Eldeen Abd Elmonem, professor

CONTACT

01112732730

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

February 18, 2022

First Posted

June 2, 2022

Study Start

June 30, 2022

Primary Completion

January 30, 2024

Study Completion

April 30, 2024

Last Updated

June 2, 2022

Record last verified: 2022-02