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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non Cardiac Chest Pain Patients | Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing. |
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| Healthy Controls | Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Esophageal Length With Acid | Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion | Length at T= 20 minutes - Baseline (T=0) |
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal Length at Symptom Onset | Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms | 20 minutes |
| Esophageal Length at Maximal Symptom Intensity | Mean length of esophagus at peak patient reported symptom intensity with acid infusion |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| William Paterson, MD, FRCPC | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu Hospital | Kingston | Ontario | K7L 5G2 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non Cardiac Chest Pain Patients | Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing. 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. |
| FG001 | Healthy Controls | Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Non Cardiac Chest Pain Patients | Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Esophageal Length With Acid | Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion | Posted | Mean | Standard Deviation | centimeters | Length at T= 20 minutes - Baseline (T=0) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non Cardiac Chest Pain Patients | Patients with Chest Pain where Coronary Artery Disease has been formally ruled out are to undergo esophageal manometry testing. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith McIntosh | Western University | 519-646-6100 | 61312 | keith.mcintosh@sjhc.london.on.ca |
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|
| 20 minutes |
| Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening | 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. | 20 minutes |
| BG001 | Healthy Controls | Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing. 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. |
|
|
| Secondary | Esophageal Length at Symptom Onset | Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms | As pre-specified in the protocol, this Outcome Measure was intended to be analyzed only if a correlation was found between esophageal shortening and symptom production. Thus data was not collected. | Posted | 20 minutes |
|
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| Secondary | Esophageal Length at Maximal Symptom Intensity | Mean length of esophagus at peak patient reported symptom intensity with acid infusion | Data Not collected given lack of correlation between symptoms and esophageal length. | Posted | 20 minutes |
|
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| Secondary | Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening | 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. | Posted | Count of Participants | Participants | 20 minutes |
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|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Healthy Controls | Healthy volunteers without esophageal symptoms are to undergo esophageal manometry testing. 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. | 0 | 19 | 0 | 19 | 0 | 19 |
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