The Signal-averaged ElectrocArdiogram in Long Term Follow-up of Chronic CHagas Disease - RIO de Janeiro Cohort (SEARCH-Rio)
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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, 1D/2D 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 a Long Term Follow-up of Subjects With Chronic Chagas 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, AV 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 an year.
Assessment by review of medical records.
- Cardiac function and dimensions [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
Non-investigational 1D/2D 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: | November 2010 |
| 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 |
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.
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| 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 | |
| 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: | September 13, 2011 |
| 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 Stroke Chagas Disease Cardiomyopathies Heart Diseases Cardiovascular Diseases Pathologic Processes |
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 May 19, 2013