NCT01442467

Brief Summary

This study aims to evaluate the accuracy of the echocardiographic data obtained from patients with calcifications in the mitral valve who are undergoing a cardiac (heart) catheterization. Echocardiography is a non-invasive (does not break the skin) procedure used to see an image of the heart. It uses harmless sound waves to create an image of the heart on a computer screen. These images will show the valves of the heart, how well the heart is pumping blood, the blood flow across these valves and how large the heart is. A silver paddle-shaped device is moved easily over the skin to capture these images. Calcification (hardening) of the heart valves and heart rings (fibrous tissue surrounding the valves) is a common finding and it increases with age. The presence of calcification changes the blood flow through the heart valves. This makes any echocardiographic data (information) obtained from patients with calcifications difficult to interpret.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 1, 2013

Status Verified

March 1, 2013

Enrollment Period

1.6 years

First QC Date

August 8, 2011

Last Update Submit

March 28, 2013

Conditions

Mitral Annulus Calcification

Keywords

mitral annular calcificationMACleft atrial pressureLAPleft ventricular end diastolic pressureLVEDPEchocardiogram

Outcome Measures

Primary Outcomes (1)

  • Agreement between invasive and non-invasive measures of LVEDP

    evaluate the agreement between the E/E' ratio by echocardiography and the left ventricular end-diastolic pressure by cardiac catheterization in patients with moderate to severe mitral annular calcification

    participants will be followed for the duration of hospital stay, an expected average of 2 days

Study Arms (2)

Mild to Severe MAC

No to mild MAC

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

elective/planned cardiac catheterization

You may qualify if:

  • \>= 19 years of age
  • undergoing planned cardiac catheterization

You may not qualify if:

  • \< 19 years of age
  • acute coronary syndrome
  • decompensated heart failure
  • not in sinus rhythm
  • \> mild MR
  • hypertensive urgency/emergency
  • severe aortic stenosis
  • poor echo windows for Doppler imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton Unviversity Medical Center

Omaha, Nebraska, 68131, United States

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2011

First Posted

September 28, 2011

Study Start

June 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 1, 2013

Record last verified: 2013-03

Locations

US(1)