The Association of Endothelial Dysfunction and Cardiac Allograft Vasculopathy

Progressive cardiac allograft vasculopathy (CAV) is a serious complication in long-term survivors after heart transplantation. Therefore, we hypothesize that CAV is a diffuse and progressive process, and endothelial function may play an important role in predicting clinical outcome after heart transplantation. Therefore, this single-blinded study is designed to evaluate endothelial function,...

Date First Received: September 11, 2005

Last Updated: September 13, 2005

Verified by: National Taiwan University Hospital, September 2005

Clinical Trial Phase: N/A | Start Date: March 2003

Overall Status: Recruiting

Estimated Enrollment: 100

Brief Summary

Condition Keyword(s):

Progressive cardiac allograft vasculopathy (CAV) is a serious complication in long-term survivors after heart transplantation. Therefore, we hypothesize that CAV is a diffuse and progressive process, and endothelial function may play an important role in predicting clinical outcome after heart transplantation. Therefore, this single-blinded study is designed to evaluate endothelial function, microvascular flow response and morphology of coronary artery in cardiac allografts,

1. The simultaneous use of IVUS and Doppler wire instrumentation in different pharmacological stress;

2. Tl-201 SPECT (dipyridamole stress/rest); to evaluate the correlation of endothelial function, coronary morphology change and Tl-201 dipyridamole stress myocardial perfusion image.

Study Type: Observational

Study Design: Natural History, Cross-Sectional, Defined Population, Prospective Study

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • 1. Heart transplant receipients who undergoing the coronary angiographic follow-up as standard protocols.

Exclusion Criteria:

  • 1. Acute illness conditions including infection, congestive heart failure (NYHA Fc III, IV), etc.
  • 2. Coronary angiographic finding: coronary stenosis>30% (as grade III, IV by Klauss V et al, Am J Cardiol 1995; 76:463-6).
  • 3. Creatinine >3.0 mg/dl

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: National Taiwan University Hospital

Overall Clinical Trial Officials and Contacts

Chii-Ming Lee, MD, phD Principal Investigator National Taiwan University Hospital  

Overall Contact: Chii-Ming Lee, MD, phD 886-2-23123456 cmlee@ha.mc.ntu.tw

Additional Information

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00173914

Study ID Number: 9200000478

ClinicalTrials.gov Identifier: NCT00173914

Health Authority: Taiwan: Department of Health

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