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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