Association of PICP Serum Marker in Patients With LVSD

• Sponsor: Texas Tech University Health Sciences Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00232388
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Systolic Dysfunction	Procedure: Blood draw

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 45 participants
• Official Title: Phase 1 Study of PICP Serum Marker of Myocardial Fibrosis and Diastolic Function in Patients With Systolic Dysfunction
• Study Start Date: Sep 1, 2005
• Actual Study Completion Date: Sep 1, 2007

Outcome Measures

Primary Outcome Measures

1. There will be a significant relationship between the severity of diastolic dysfunction and PICP []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	TTUHSC	Lubbock	Texas	United States	79430

Sponsors and Collaborators

• Texas Tech University Health Sciences Center

Investigators

• Principal Investigator: Chanwit Roongsritong, MD, TTUHSC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00232388
• Other Study ID Numbers: L06-006
• First Posted: Oct 4, 2005
• Last Update Posted: Oct 7, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by , ,: Ejection Fraction <35%
• Additional relevant MeSH terms: Systolic Murmurs

Study Results

No Results Posted as of Oct 7, 2015