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The Association of Endothelial Dysfunction and Cardiac Allograft Vasculopathy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00173914
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose

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.

Condition
Heart Transplantation

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 100
Study Start Date: March 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00173914


Contacts
Contact: Chii-Ming Lee, MD, phD 886-2-23123456 ext 5057 cmlee@ha.mc.ntu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chii-Ming Lee, MD, phD    886-2-23123456 ext 5057    cmlee@ha.mc.ntu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chii-Ming Lee, MD, phD National Taiwan University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00173914     History of Changes
Other Study ID Numbers: 9200000478
NTUH 92M011
First Submitted: September 11, 2005
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by National Taiwan University Hospital:
1. Transplant vasculopathy
2. Endothelial dysfunction
3. Myocardial perfusion imaging
4. Intravascular vascular ultrasound