Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000299000
Ethics application status
Approved
Date submitted
9/04/2010
Date registered
14/04/2010
Date last updated
14/04/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Trypanosoma cruzi lineages and Chagas disease manifestations in cardiac unit patients from three endemic areas of Ecuador
Scientific title
Evaluation of the prevalence of the cardiac form of Chagas disease and performance of rapid diagnostic tests in hospitals of endemic areas of Ecuador
Secondary ID [1] 1600 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Chagas disease 256526 0
Condition category
Condition code
Cardiovascular 256696 256696 0 0
Other cardiovascular diseases
Infection 256697 256697 0 0
Studies of infection and infectious agents
Infection 256698 256698 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Evaluation of types and prevalence of electrocardiographic abnormalities in cardiac patients suffering from Chagas disease at the time of recrutiment into the study. Although the participation of each participant is limited to the time in which he/she is recruited into the study, participant recruitment is expected to span a total of 36 months.
Intervention code [1] 255805 0
Not applicable
Comparator / control treatment
Types and prevalence of electrocardiographic abnormalities in cardiac patients not suffering from Chagas disease
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257586 0
Chagas disease seroprevalence
Timepoint [1] 257586 0
At the time of patient recruitment
Secondary outcome [1] 262841 0
Electrocardiographic abnormalities (right bundle branch block, left bundle branch block, ventricular extrasystoles, altered ventricular repolarization, Q-waves, Atrioventricular block, sinoatrial node disfunction, supraventricular tachiarrithmia, atrial fibrilation)
Timepoint [1] 262841 0
At the time of patient recruitment

Eligibility
Key inclusion criteria
All patients obtaining medical care at public hospitals in areas endemic for Chagas disease in Ecuador will be invited to participate in the study. All races will be included.
Minimum age
1 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patients age one or younger will be excluded due to the difficulty of drawing blood from them and the discomfort they would suffer. If consent from the legal representative of a minor cannot be obtained at the time of the visit to the cardiologist, the minor will be excluded from the study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment outside Australia
Country [1] 2402 0
Ecuador
State/province [1] 2402 0

Funding & Sponsors
Funding source category [1] 256812 0
Other
Name [1] 256812 0
Special Programme for Research and Training in Tropical Diseases-World Health Organization
Country [1] 256812 0
Switzerland
Primary sponsor type
Individual
Name
Jaime Costales
Address
Edificio de Quimica, PB # 004
Pontificia Universidad Catolica del Ecuador
Avenida 12 de Octubre y Roca
Quito-Ecuador
Country
Ecuador
Secondary sponsor category [1] 256093 0
None
Name [1] 256093 0
Address [1] 256093 0
Country [1] 256093 0
Other collaborator category [1] 1025 0
University
Name [1] 1025 0
Catholic University
Address [1] 1025 0
Pontificia Universidad Catolica del Ecuador
Avenida 12 de Octubre y Roca
Quito-Ecuador
Country [1] 1025 0
Ecuador
Other collaborator category [2] 1027 0
Individual
Name [2] 1027 0
Mario Grijalva, Ph.D.
Address [2] 1027 0
Irvine Hall 333
Athens, OH
45701
Country [2] 1027 0
United States of America
Other collaborator category [3] 1028 0
Hospital
Name [3] 1028 0
Regional Hospital Verdi Cevallos Balda
Address [3] 1028 0
Interseccion of 12 de Marzo Avenue and Rocafuerte Avenue
Portoviejo City, Manabi, Ecuador
Country [3] 1028 0
Ecuador
Other collaborator category [4] 1029 0
Hospital
Name [4] 1029 0
Social Security Hospital, Portoviejo
Address [4] 1029 0
Manabi Avenue and Manuel Palomeque St.
Portoviejo city, Manabi, Ecuador
Country [4] 1029 0
Ecuador
Other collaborator category [5] 1030 0
Hospital
Name [5] 1030 0
Isidro Ayora Regional Hospital
Address [5] 1030 0
Intersection of Manuel Aguirre Avenue and Juan Jose Samaniego Avenue
Loja City, Loja, Ecuador
Country [5] 1030 0
Ecuador
Other collaborator category [6] 1031 0
Hospital
Name [6] 1031 0
Teofilo Davila Regional Hospital
Address [6] 1031 0
Intersection of Buenavista Street and Boyaca Street
Machala city, El Oro, Ecuador
Country [6] 1031 0
Ecuador

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258383 0
World Health Organization [WHO] Ethics Research Committe
Ethics committee address [1] 258383 0
Ethics committee country [1] 258383 0
Switzerland
Date submitted for ethics approval [1] 258383 0
Approval date [1] 258383 0
08/03/2010
Ethics approval number [1] 258383 0
A90037
Ethics committee name [2] 258808 0
Ethics Committee from Pontificia Universidad Catolica del Ecuador
Ethics committee address [2] 258808 0
Ethics committee country [2] 258808 0
Ecuador
Date submitted for ethics approval [2] 258808 0
Approval date [2] 258808 0
15/01/2010
Ethics approval number [2] 258808 0

Summary
Brief summary
The study intends to determine the prevalence of cardiac damages associated with Chagas disease among patients of hospitals of endemic areas of Ecuador and to evaluate the performance of rapid diagnostic tests to be performed in such settings. We hypothesis that many of the patients attenging the hospital cardiac wards in endemic areas suffer from Chagas disease and that the use of rapid diagnostic tests might help the hospitals to attain better diagnosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30695 0
Address 30695 0
Country 30695 0
Phone 30695 0
Fax 30695 0
Email 30695 0
Contact person for public queries
Name 13942 0
Jaime Costales
Address 13942 0
Edificio de Quimica, PB # 004
Pontificia Universidad Catolica del Ecuador Avenida 12 de Octubre y Roca, Quito-Ecuador
Country 13942 0
Ecuador
Phone 13942 0
(593)2-2991-700, ext 1856
Fax 13942 0
Email 13942 0
jacostalesc@puce.edu.ec
Contact person for scientific queries
Name 4870 0
Jaime Costales
Address 4870 0
Edificio de Quimica, PB # 004
Pontificia Universidad Catolica del Ecuador Avenida 12 de Octubre y Roca, Quito-Ecuador
Country 4870 0
Ecuador
Phone 4870 0
(593)2-2991-700, ext 1856
Fax 4870 0
Email 4870 0
jacostalesc@puce.edu.ec

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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