NCT02027350

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

1.9 years

First QC Date

December 31, 2013

Last Update Submit

November 3, 2016

Conditions

Constrictive Pericarditis

Outcome Measures

Primary Outcomes (1)

  • Presence of constrictive pericarditis

    1 hour

Study Arms (1)

Pressure-volume relationship

EXPERIMENTAL

Changes in pressure-volume relationships will be compared to changes in LV and RV systolic pressure during respiration.

Device: CD Leycom/Millar Instruments conductance catheter

Interventions

CD Leycom/Millar Instruments conductance catheterDEVICE

Conductance catheter-Pressure volume relationship

Pressure-volume relationship

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Subjects referred for right and left heart catheterization will be eligible.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pericarditis, Constrictive

Condition Hierarchy (Ancestors)

PericarditisHeart DiseasesCardiovascular Diseases

Study Officials

  • Barry Borlaug, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

December 31, 2013

First Posted

January 6, 2014

Study Start

December 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations

US(1)