NCT00173914

Brief 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. 1.The simultaneous use of IVUS and Doppler wire instrumentation in different pharmacological stress;
  2. 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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 15, 2005

Status Verified

September 1, 2005

First QC Date

September 11, 2005

Last Update Submit

September 13, 2005

Conditions

Heart Transplantation

Keywords

1. Transplant vasculopathy2. Endothelial dysfunction3. Myocardial perfusion imaging4. Intravascular vascular ultrasound

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

  • Chii-Ming Lee, MD, phD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chii-Ming Lee, MD, phD

CONTACT

886-2-23123456cmlee@ha.mc.ntu.tw

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 15, 2005

Study Start

March 1, 2003

Last Updated

September 15, 2005

Record last verified: 2005-09

Locations

TW(1)