Association of PICP Serum Marker in Patients With LVSD

This study has been terminated.
(PI left institution; Data collected from 45 participants, but no results are available.)
Sponsor:
Information provided by:
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00232388
First received: October 3, 2005
Last updated: December 28, 2010
Last verified: December 2010
  Purpose

The purpose of this study is to determine if the carboxy-terminal of procollagen type I (PICP) can be a useful marker of different degrees of myocardial fibrosis.


Condition Intervention Phase
Systolic Dysfunction
Procedure: Blood draw
Phase 1

Study Type: Observational
Official Title: Phase 1 Study of PICP Serum Marker of Myocardial Fibrosis and Diastolic Function in Patients With Systolic Dysfunction

Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • There will be a significant relationship between the severity of diastolic dysfunction and PICP [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

PLEASE NOTE THAT THE INVESTIGATOR LEFT THE INSTITUION WITHOUT PROVIDING ANY INFORMATION REGARDING THIS PROJECT. NO FORWARDING INFORMATION IS AVAILABLE FROM THE INVESTIGATOR.


Enrollment: 45
Study Start Date: September 2005
Study Completion Date: September 2007
Detailed Description:

Abnormality of diastolic function, particularly a more advanced form known as restrictive tilling pattern, has been correlated with worse outcome in patients with systolic dysfunction associated with chronic heart failure or following an acute myocardial infarction. Recently, the severity of diastolic dysfunction has also been shown to predict the response to cardiac synchronization therapy for refractory heart failure due to systolic dysfunction.

Varying degree of diastolic dysfunction has been reported among patients with comparable severity of systolic dysfunction. The underlying mechanisms responsible for the observed discordance between systolic and diastolic dysfunction in these patients remains incompletely understood.

The carboxy-terminal of procollagen type I (PICP), a peptide that is cleaved from procollagen type I during the synthesis of fibril-forming collagen type I, has been associated with myocardial fibrosis. Myocardial fibrosis is a major determinant of both systolic and diastolic function of the heart. We hypothesize that differential degrees of myocardial fibrosis may be responsible for these discrepancies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Persons with left ventricular systolic dysfunction from the Texas Tech University Health Sciences Center outpatient clinic and University Medical Center, Lubbock, Texas

Criteria

Inclusion Criteria:

  1. Evidence of left ventricular systolic dysfunction (measured LVEF% less than 35%) measured by echocardiography within the previous three months at the time of enrollment
  2. Greater than or equal to 18 years of age
  3. Greater than or equal to 110 pounds in weight

Exclusion Criteria:

1.Non-sinus rhythm at the time of enrollment

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232388

Locations
United States, Texas
TTUHSC
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Chanwit Roongsritong, MD TTUHSC
  More Information

No publications provided

Responsible Party: Chanwith Roongsritong, MD
ClinicalTrials.gov Identifier: NCT00232388     History of Changes
Other Study ID Numbers: L06-006
Study First Received: October 3, 2005
Last Updated: December 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Ejection Fraction <35%

ClinicalTrials.gov processed this record on July 08, 2014