Back to resultsNew Methods to Diagnose Constrictive Pericarditis
Primary Purpose
Constrictive Pericarditis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CD Leycom/Millar Instruments conductance catheter
Sponsored by
About this trial
This is an interventional diagnostic trial for Constrictive Pericarditis
Eligibility Criteria
Subjects referred for right and left heart catheterization will be eligible.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pressure-volume relationship
Arm Description
Changes in pressure-volume relationships will be compared to changes in LV and RV systolic pressure during respiration.
Outcomes
Primary Outcome Measures
Presence of constrictive pericarditis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02027350
Brief Title
New Methods to Diagnose Constrictive Pericarditis
Official Title
Pressure-Volume Analysis of Constrictive Pericarditis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
due lack of subjects
Study Start Date
December 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Until now, diagnosis of constriction was based on pressure changes of ventricle by conventional pressure-wide hemodynamic evaluation but not on ventricular volume change. This study will provide answers to persisting questions about volume changes during respiration in patients with constrictive pericarditis by directly measuring both right and left ventricular volume.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constrictive Pericarditis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pressure-volume relationship
Arm Type
Experimental
Arm Description
Changes in pressure-volume relationships will be compared to changes in LV and RV systolic pressure during respiration.
Intervention Type
Device
Intervention Name(s)
CD Leycom/Millar Instruments conductance catheter
Intervention Description
Conductance catheter-Pressure volume relationship
Primary Outcome Measure Information:
Title
Presence of constrictive pericarditis
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subjects referred for right and left heart catheterization will be eligible.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Borlaug, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
New Methods to Diagnose Constrictive Pericarditis
We'll reach out to this number within 24 hrs