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The Signal-averaged ElectrocArdiogram in Long Term Follow-up of Chronic CHagas Disease - RIO de Janeiro Cohort

NCT01340963 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2013-12-10

No results posted yet for this study

Summary

The study investigated 100 subjects, both genders, with chronic Chagas disease, confirmed by at least two distinct serological tests, and classified according to Los Andes classification in a long term follow-up aiming at identifying the predictive value of the signal-averaged electrocardiogram for cardiac death and ventricular tachycardia.

All subjects admitted to the study were submitted to clinical history taking, physical examination, and noninvasive assessment, including blood pressure measurement, resting 12-lead surface electrocardiogram, 24h ambulatory electrocardiogram monitoring, M-Mode/two-dimensional echocardiogram, signal-averaged electrocardiogram in both time and frequency domains. Selected subjects were further submitted to treadmill stress test and coronary angiography to rule out coronary heart disease.

Subjects were followed by non-investigational primary care assistance at three to six months scheduled clinical visits on an outpatients basis. Both noninvasive and invasive evaluation during follow-up were requested at discretion of primary evaluation. Adverse outcomes were ascertained by review of medical records and active contact to either study subjects or their relatives.

Conditions

  • Chagas Cardiomyopathy
  • Cardiac Arrhythmia
  • Stroke
  • Left Ventricular Function Systolic Dysfunction
  • Cardiac Death

Sponsors & Collaborators

  • Rio de Janeiro State University

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • Instituto Nacional de Cardiologia de Laranjeiras

    collaborator OTHER

  • Universidade Gama Filho

    lead OTHER

Principal Investigators

  • Paulo R Benchimol-Barbosa, MD, DSc · Rio de Janeiro State University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-06-30
Primary Completion
2001-03-31
Completion
2012-12-31

Countries

  • United States
  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01340963 on ClinicalTrials.gov