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

NCT01340963 | Completed DMC

• 1 other identifier: 012345/96
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 4

Brief 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

Keywords

Chagas heart disease; ventricular tachycardia; atrial fibrillation; stroke; cardiac death; signal averaged electrocardiogram

Outcome Measures

Primary Outcomes (1)

• Cardiac death [Time Frame: up to 10 years ]

  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.

  up tp 10 years

Secondary Outcomes (4)

• Ventricular tachycardia

  up to ten years

• Stroke, either fatal or nonfatal

  up to 10 years

• Persistent atrial fibrillation

  up to 10 years

• Cardiac function and dimensions

  up to 10 years

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Gama Filho: lead
• Rio de Janeiro State University: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Instituto Nacional de Cardiologia de Laranjeiras: collaborator

Study Sites (4)

University of Texas at Houston

Houston, Texas, 77030, United States

Location

Hospital Universitário Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, 20551-900, Brazil

Location

Universidade Gama Filho

Rio de Janeiro, Rio de Janeiro, 20740-900, Brazil

Location

Instituto Nacional de Cardiologia

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Related Publications (18)

• Benchimol-Barbosa PR, Nasario-Junior O, Nadal J. The effect of configuration parameters of time-frequency maps in the detection of intra-QRS electrical transients of the signal-averaged electrocardiogram: impact in clinical diagnostic performance. Int J Cardiol. 2010 Nov 5;145(1):59-61. doi: 10.1016/j.ijcard.2009.04.013. Epub 2009 May 9.

  PMID: 19428130 BACKGROUND

• Benchimol-Barbosa PR, Muniz RT. Ventricular late potential duration correlates to the time of onset of electrical transients during ventricular activation in subjects post-acute myocardial infarction. Int J Cardiol. 2008 Sep 26;129(2):285-7. doi: 10.1016/j.ijcard.2007.05.057. Epub 2007 Aug 10.

  PMID: 17692944 BACKGROUND

• Benchimol-Barbosa PR. Trends on acute Chagas' disease transmitted by oral route in Brazil: steady increase in new cases and a concealed residual fluctuation. Int J Cardiol. 2010 Dec 3;145(3):494-6. doi: 10.1016/j.ijcard.2009.08.030. Epub 2009 Sep 16. No abstract available.

  PMID: 19762096 BACKGROUND

• Benchimol-Barbosa PR, Barbosa-Filho J. Mechanical cardiac remodeling and new-onset atrial fibrillation in long-term follow-up of subjects with chronic Chagas' disease. Braz J Med Biol Res. 2009 Mar;42(3):251-62. doi: 10.1590/s0100-879x2009000300006.

  PMID: 19287904 RESULT

• Benchimol-Barbosa PR. Predictors of mortality in Chagas' disease: the impact of atrial fibrillation and oral transmission on infected population. Int J Cardiol. 2009 Apr 3;133(2):275-7. doi: 10.1016/j.ijcard.2007.11.053. Epub 2008 Jan 15.

  PMID: 18199497 RESULT

• Benchimol-Barbosa PR. Cardiac remodeling and predictors for cardiac death in long-term follow-up of subjects with chronic Chagas' heart disease: a mathematical model for progression of myocardial damage. Int J Cardiol. 2009 Jan 24;131(3):435-8. doi: 10.1016/j.ijcard.2007.07.151. Epub 2007 Nov 28.

  PMID: 18053595 RESULT

• Benchimol-Barbosa PR, Barbosa-Filho J. Atrial mechanical remodeling and new onset atrial fibrillation in chronic Chagas' heart disease. Int J Cardiol. 2008 Jul 21;127(3):e113-5. doi: 10.1016/j.ijcard.2007.04.103. Epub 2007 Aug 8.

  PMID: 17689724 RESULT

• Benchimol-Barbosa PR. Nonlinear mathematical model for predicting long term cardiac remodeling in Chagas' heart disease: introducing the concepts of 'limiting cardiac function' and 'cardiac function deterioration period'. Int J Cardiol. 2010 Nov 19;145(2):219-221. doi: 10.1016/j.ijcard.2009.05.010. Epub 2009 May 27.

  PMID: 19477538 RESULT

• Benchimol-Barbosa PR, Kantharia BK, Carvalhaes CG. Nonlinear Dynamics in Long-Term Left Ventricular Remodeling in Chagas Heart Disease and Adverse Outcomes: SEARCH-Rio Substudy. Circulation Research. 2012;111:A351

  RESULT

• Benchimol-Barbosa PR, Tura BR, Barbosa E, Barbosa-Filho J, Kantharia BK. A Novel Risk Score Based on Noninvasive ECG Monitoring Aiming at Predicting Ventricular Tachycardia and Cardiac Death in Chronic Chagas Disease. Circulation. 2010; 122: A19759.

  RESULT

• Benchimol Barbosa PR. Noninvasive prognostic markers for cardiac death and ventricular arrhythmia in long-term follow-up of subjects with chronic Chagas' disease. Braz J Med Biol Res. 2007 Feb;40(2):167-78.

  PMID: 17273653 RESULT

• Benchimol-Barbosa PR, Duque GS, Barbosa-Filho J. Long term cardiac remodelling in chronic Chagas' heart disease. Eur Heart J; 2008. 29(suppl 1): 441-441. doi:10.1093/eurheartj/ehn375

  RESULT

• Benchimol-Barbosa PR, Duque GS, Barbosa EC, Bomfim AS, Dantas-Carletti MS, Barbosa-Filho J. High spectral turbulence in signal-averaged electrocardiogram is an independent predictor for cardiac death in long-term follow-up of subjects with chronic Chagas disease. Eur Heart J; 2009. 30(suppl 1): 697-697. doi:10.1093/eurheartj/ehp415

  RESULT

• Benchimol-Barbosa PR, Tura BR, Barbosa EC, Barbosa-Filho J, Kantharia BK. A novel risk score for predicting cardiac death in chronic chagas heart disease based on spectral turbulence analysis of the signal-averaged ECG. Eur Heart J; 2010. 31(suppl 1): 163-163. doi:10.1093/eurheartj/ehq287

  RESULT

• Benchimol-Barbosa PR, Tura BR, Barbosa-Filho J, Kantharia BK. Increasing 24h incidence of isolated PVC is associated with growing complexity and incidence of cardiac tachyarrhythmia in Chagas heart disease. Eur Heart J; 2010. 31(suppl 1): 480-480. doi:10.1093/eurheartj/ehq288

  RESULT

• Benchimol-Barbosa PR. Clinical characteristics of spontaneous ventricular tachycardia episodes associated with unfavorable prognosis in chronic Chagas disease. Eur Heart J; 2010. 31(suppl 1): 480-480. doi:10.1093/eurheartj/ehq288

  RESULT

• PR Benchimol-Barbosa. Ventricular tachyarrhythmic events triggers in chronic Chagas disease. Eur Heart J; 2010. 31(suppl 1): 481-481. doi:10.1093/eurheartj/ehq288

  RESULT

• Benchimol-Barbosa PR, Tura BR, Barbosa EC, Kantharia BK. Utility of a novel risk score for prediction of ventricular tachycardia and cardiac death in chronic Chagas disease - the SEARCH-RIO study. Braz J Med Biol Res. 2013 Nov;46(11):974-984. doi: 10.1590/1414-431X20133141. Epub 2013 Oct 22.

  PMID: 24270912 RESULT

MeSH Terms

Conditions

Chagas Cardiomyopathy; Arrhythmias, Cardiac; Stroke; Death; Tachycardia, Ventricular; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Chagas Disease; Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Paulo R Benchimol-Barbosa, MD, DSc

  Rio de Janeiro State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Researcher

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 25, 2011
• Study Start: June 1, 1995
• Primary Completion: March 1, 2001
• Study Completion: December 1, 2012
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

US (1); BR (3)