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OpenTrials
Completed

NCT Number: NCT01839058

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

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.

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Key information

Conditions

Chest Pain Atypical Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophageal Manometry

Other

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.

Primary outcomes

  1. Mean Change in Esophageal Length With Acid

    Time frame: Length at T= 20 minutes - Baseline (T=0)

    Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion

Secondary outcomes

  1. Esophageal Length at Symptom Onset

    Time frame: 20 minutes

    Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms

  2. Esophageal Length at Maximal Symptom Intensity

    Time frame: 20 minutes

    Mean length of esophagus at peak patient reported symptom intensity with acid infusion

  3. Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening

    Time frame: 20 minutes

    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.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 24, 2013
Registry last updated
Nov 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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