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

Completed

Conditions studied: Chagas Cardiomyopathy, Cardiac Arrhythmia, Stroke, Left Ventricular Function Systolic Dysfunction, Cardiac Death

In brief

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.

Key facts

Study ID

NCT01340963

Run by

Universidade Gama Filho

People needed

100

Starts

1995-06-01

Expected to finish

2012-12-01

Last updated by the study team

2013-12-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Texas at Houston — Houston, Texas, United States
• Hospital Universitário Pedro Ernesto — Rio de Janeiro, Rio de Janeiro, Brazil
• Universidade Gama Filho — Rio de Janeiro, Rio de Janeiro, Brazil
• Instituto Nacional de Cardiologia — Rio de Janeiro, Rio de Janeiro, Brazil

Full record on ClinicalTrials.gov

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