The Association of Endothelial Dysfunction and Cardiac Allograft Vasculopathy

Heart Transplantation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00173914
• Other study ID #: 9200000478
• Secondary ID: NTUH 92M011
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2005
• Last updated: September 13, 2005
• Start date: March 2003

Study information

• Verified date: September 2005
• Source: National Taiwan University Hospital
• Contact: Chii-Ming Lee, MD, phD
• Phone: 886-2-23123456
• Email: cmlee[@]ha.mc.ntu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Heart Transplantation

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,