The Signal-averaged ElectrocArdiogram in Long Term Follow-up of Chronic CHagas Disease - RIO de Janeiro Cohort (SEARCH-Rio)
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.
Left Ventricular Function Systolic Dysfunction
|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|
- 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.
- 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.
|Study Start Date:||June 1995|
|Study Completion Date:||December 2012|
|Primary Completion Date:||March 2001 (Final data collection date for primary outcome measure)|
Structurally normal heart, no bundle branch block
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
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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01340963
|United States, Texas|
|University of Texas at Houston|
|Houston, Texas, United States, 77030|
|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|
|Principal Investigator:||Paulo R Benchimol-Barbosa, MD, DSc||Rio de Janeiro State University|