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

This study has been completed.
Sponsor:
Collaborators:
Rio de Janeiro State University
The University of Texas Health Science Center, Houston
Instituto Nacional de Cardiologia de Laranjeiras
Information provided by (Responsible Party):
Paulo Roberto Benchimol Barbosa, Universidade Gama Filho
ClinicalTrials.gov Identifier:
NCT01340963
First received: April 21, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of the Spectral Turbulence Analysis of the Signal-averaged Electrocardiogram in Chagas Heart Disease

Resource links provided by NLM:


Further study details as provided by Universidade Gama Filho:

Primary Outcome Measures:
  • Cardiac death [Time Frame: up to 10 years ] [ Time Frame: up tp 10 years ] [ Designated as safety issue: No ]

    Defined as intractable heart failure, arrhythmic, coronary occlusion, or sudden death.

    Assessment twice an year by active and direct contact to subjects or relatives and review of medical records.



Secondary Outcome Measures:
  • Ventricular tachycardia [ Time Frame: up to ten years ] [ Designated as safety issue: No ]

    New onset ventricular tachycardia defined as symptomatic (palpitations, dizziness or syncope), >=3 consecutive beats, bundle branch block configuration, ventricular rate >100bpm, atrial-ventricular dissociation.

    Assessed with 24h-ambulatory electrocardiogram monitoring requested at discretion of non-investigational primary evaluation and confirmed by review of medical records.


  • Stroke, either fatal or nonfatal [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

    Evidence of clinically definite stroke (focal neurological deficits persisting for more than 24 hours) confirmed or not by non-investigational CT.

    Assessment twice an year by active and direct contact to patents or relatives and review of medical records.


  • Persistent atrial fibrillation [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

    Irregular non-sinus interbeat interval, lasting more that 24h, confirmed by either non-investigational 24h ambulatory electrocardiogram monitoring or resting 12-lead surface electrocardiogram two to four times a year.

    Assessment by review of medical records.


  • Cardiac function and dimensions [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

    Non-investigational M-mode/2-D echocardiographic evaluation at the discretion of primary care assistance.

    Assessment by review of medical records.



Enrollment: 100
Study Start Date: June 1995
Study Completion Date: December 2012
Primary Completion Date: March 2001 (Final data collection date for primary outcome measure)
Groups/Cohorts
Class I
Structurally normal heart, no bundle branch block
Class II
Mild symptoms, bundle brunch block or hemi-block on resting surface electrocardiogram, normal cardiac silhouette on plain chest X-ray film, left ventricular diastolic dysfunction as relaxation deficit (type I), none or mild global left ventricular systolic dysfunction
Class III
Overtly symptomatic, enlarged cardiac silhouette on plain chest X-ray film, left ventricular diastolic dysfunction, global systolic dysfunction, ventricular tachycardia, atrio-ventricular block (any degree)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

One hundred clinically stable subjects with at least 10 years of regular outpatients follow-up and positive epidemiological history and serological confirmation of Chagas disease with ate least two immunological tests.

Criteria

Inclusion Criteria:

  • Clinically stable outpatients with at least 10 years of regular outpatients follow-up and positive epidemiological history and serological confirmation of Chagas disease with ate least two immunological tests

Exclusion Criteria:

  • Any degree of atrioventricular block or non-sinus rhythm
  • Previous documented acute coronary events (due to documented obstructive epicardial coronary vessels)
  • Chronic obstructive pulmonary disease
  • Rheumatic valvular heart disease
  • Alcohol addiction
  • Thyroid dysfunction
  • Abnormal serum electrolytes and biochemical abnormalities
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01340963

Locations
United States, Texas
University of Texas at Houston
Houston, Texas, United States, 77030
Brazil
Hospital Universitário Pedro Ernesto
Rio de Janeiro, RJ, Brazil, 20551-900
Instituto Nacional de Cardiologia
Rio de Janeiro, RJ, Brazil
Universidade Gama Filho
Rio de Janeiro, RJ, Brazil, 20740-900
Sponsors and Collaborators
Universidade Gama Filho
Rio de Janeiro State University
The University of Texas Health Science Center, Houston
Instituto Nacional de Cardiologia de Laranjeiras
Investigators
Principal Investigator: Paulo R Benchimol-Barbosa, MD, DSc Rio de Janeiro State University
  More Information

Publications:

Responsible Party: Paulo Roberto Benchimol Barbosa, Head Researcher, Universidade Gama Filho
ClinicalTrials.gov Identifier: NCT01340963     History of Changes
Other Study ID Numbers: 012345/96
Study First Received: April 21, 2011
Last Updated: December 9, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Gama Filho:
Chagas heart disease
ventricular tachycardia
atrial fibrillation
stroke
cardiac death
signal averaged electrocardiogram

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Chagas Cardiomyopathy
Death
Heart Diseases
Stroke
Cardiomyopathies
Cardiovascular Diseases
Pathologic Processes
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014