Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. William Paterson, Queen's University
ClinicalTrials.gov Identifier:
NCT01839058
First received: April 16, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

Non-cardiac chest pain (NCCP) is a common disorder whose pathophysiology is poorly understood. Some evidence suggests it may be related to sustained esophageal contractions (SECs) of longitudinal smooth muscle. The investigators have previously shown that acid is a trigger for SECs and results in shortening of the esophagus. In this study, the investigators plan to prospectively evaluate esophageal shortening responses to acid in a group of patients with NCCP compared to controls. The investigators will use high resolution esophageal manometry coupled with acid infusion to evaluate shortening. The investigators hypothesize that at least a subset of patients with NCCP will have an exaggerated esophageal shortening response to acid which correlates with symptom production. If our hypothesis proves true, this may lead to a future therapeutic target in the treatment of these patients.


Condition Intervention
Chest Pain Atypical Syndrome
Other: Esophageal Manometry

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Mean change in esophageal length with acid [ Time Frame: Length at T= 20 minutes - Baseline (T=0) ] [ Designated as safety issue: No ]
    Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion


Secondary Outcome Measures:
  • Esophageal length at symptom onset [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms

  • Esophageal length at maximal symptom intensity [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    Mean length of esophagus at peak patient reported symptom intensity with acid infusion

  • Correlation between symptom onset and esophageal shortening [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    Esophageal shortening will be defined as the point during the 20 minute acid infusion at which the lower esophageal sphincter begins to migrate proximally. A 2 minute window following this time point will then be used to determine if patients symptoms increased by > 2 on a visual analogue pain scale between 0 - 10.


Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non Cardiac Chest Pain Patients
Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing.
Other: Esophageal Manometry
Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.
Healthy Controls
Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing.
Other: Esophageal Manometry
Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with non cardiac chest pain as diagnosed by cardiologist or other physician. Healthy Volunteers will include anyone in the Kingston area who fulfils Inclusion and Exclusion criteria.

Criteria

Inclusion Criteria:

  • Healthy volunteers:
  • free of esophageal symptoms
  • not on any acid suppressing medications
  • Non Cardiac Chest Pain Patients:
  • Angina like chest pain occuring at least once per month
  • Coronary artery disease ruled out by stress test or angiogram

Exclusion Criteria:

  • pre existing motility disorder of the esophagus
  • connective tissue disease
  • pregnancy
  • taking calcium channel blockers, Nitrates, Gabapentin, Narcotics, Tricyclic antidepressants, Anti seizure medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839058

Locations
Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: William Paterson, MD, FRCPC Queen's University
  More Information

No publications provided

Responsible Party: Dr. William Paterson, Professor of Medicine, Queen's University
ClinicalTrials.gov Identifier: NCT01839058     History of Changes
Other Study ID Numbers: DMED-1559-13
Study First Received: April 16, 2013
Last Updated: May 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Non Cardiac Chest Pain

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014