NCT00155779

Brief Summary

The acute respiratory distress syndrome (ARDS) is an important cause of acute respiratory failure with a high mortality rate. The mechanism of resolution of the late organizing phase remains uncertain. The ACE gene contains a polymorphism based on the presence (insertion, I) or absence (deletion, D) within an intron of a 287-bp nonsense DNA domain, resulting in three genotypes (DD and II homozygotes, and ID heterozygotes). It has been shown that I/D polymorphism of ACE gene may account for half the variance of serum ACE levels in the Caucasians. Polymorphism of the ACE gene has also been shown to contribute to the development of some respiratory diseases. We hypothesize that the presence of ACE gene polymorphism can affect the outcome of ARDS. The objective of this proposed study is to determine the genotypes of ACE gene polymorphism and assess the influence of ACE genotype on the outcome and pulmonary resolution of patients with ARDS. Patients diagnosed to have ARDS are eligible for possible inclusion into the study. The ACE genotype of all patients with ARDS will be determined by polymerase chain reaction (PCR) amplification of the respective fragment for the D and I alleles from intron 16 of the ACE gene and size fractionation by electrophoresis. The outcome of patients with ARDS in the three genotypes will be compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2003

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 12, 2005

Status Verified

December 1, 2003

First QC Date

September 9, 2005

Last Update Submit

September 9, 2005

Conditions

Keywords

adult respiratory distress syndromeangiotensin-converting enzymepolymorphism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with acute respiratory distress syndrome requiring intensive care and mechanical ventilation

You may not qualify if:

  • Pregnancy
  • History of previous acute respiratory distress syndrome
  • Chronic respiratory failure with ventilator use
  • Receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blocker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Pan-Chyr Yang, MD, PhD

    Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

December 1, 2003

Study Completion

December 1, 2004

Last Updated

September 12, 2005

Record last verified: 2003-12

Locations