NCT01980862

Brief Summary

Single-site blood collection investigation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

3 months

First QC Date

November 5, 2013

Last Update Submit

August 4, 2014

Conditions

To Measure Galectin-3 in Heart Failure Patients on Commercial Platforms

Outcome Measures

Primary Outcomes (1)

  • Obtain 45 matched donor serum and plasma samples sets collected from Heart Failure patients for galectin-3 measurements

    6 months

Study Arms (1)

Heart Failure patients

No interventions for this study. Blood draw provided by patients.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

45 matched door serum and plasma. Samples set collected form individual Heart Failure patients for galecin-3 measurements

You may qualify if:

  • Heart Failure patients New York Heart Association class able to provide (4) collection tube types Subjects \> 18 years old All subjects must provide informed consent and associated documentation

You may not qualify if:

  • Subjects that cannot tolerate blood withdrawal of 4 specimens collection tube tubes (approximately 40 mLs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Study Officials

  • Robert Christenson, MD

    Universtiy of Maryland School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2013

First Posted

November 11, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

US(1)