Trial Outcomes & Findings for Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction? (NCT NCT01839058)
NCT ID: NCT01839058
Last Updated: 2018-11-26
Results Overview
Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion
Recruitment status
COMPLETED
Target enrollment
40 participants
Primary outcome timeframe
Length at T= 20 minutes - Baseline (T=0)
Results posted on
2018-11-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?
Baseline characteristics by cohort
| Measure |
Non Cardiac Chest Pain Patients
n=17 Participants
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.
|
Healthy Controls
n=16 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.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 18.3 • n=7 Participants
|
50.9 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Length at T= 20 minutes - Baseline (T=0)Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion
Outcome measures
| Measure |
Non Cardiac Chest Pain Patients
n=17 Participants
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.
|
Healthy Controls
n=16 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.
|
|---|---|---|
|
Mean Change in Esophageal Length With Acid
|
-0.40 centimeters
Standard Deviation 0.54
|
-0.39 centimeters
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: 20 minutesPopulation: 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.
Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 minutesPopulation: Data Not collected given lack of correlation between symptoms and esophageal length.
Mean length of esophagus at peak patient reported symptom intensity with acid infusion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 minutesEsophageal 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.
Outcome measures
| Measure |
Non Cardiac Chest Pain Patients
n=17 Participants
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.
|
Healthy Controls
n=16 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.
|
|---|---|---|
|
Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening
|
0 Participants
|
0 Participants
|
Adverse Events
Non Cardiac Chest Pain Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place