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临床试验/NCT01340963
NCT01340963已完成不适用

Prognostic Value of the Spectral Turbulence Analysis of the Signal-averaged Electrocardiogram in Chagas Heart Disease

Universidade Gama Filho4 个研究点 分布在 2 个国家目标入组 100 人开始时间: 1995年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
4
主要终点
Cardiac death [Time Frame: up to 10 years ]

研究概览

简要总结

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.

详细描述

Admission:

Longitudinal prospective study, with a cohort of 100 consecutive outpatient subjects (34 to 74 years old; 31 females) with Chagas' disease followed-up for at least 10 years at the cardiomyopathy outpatient clinic of University Hospital, Rio de Janeiro, RJ, Brazil, a tertiary care center. Enrollment was from 1995 to 1999. Subjects were born in endemic regions of Minas Gerais, Goias or Bahia States of Brazil and Chagas' disease was diagnosed on basis of two positive serum tests, hemagglutination cruzipain-ELISA and indirect immunofluorescence. All subjects were referred to the arrhythmia for risk stratification. At the time of admission none had received nitroderivative therapy. Subjects were classified according to the severity of heart involvement according to Los Andes classification, and divided into three groups: class I - 28 subjects (group 1), class II - 48 subjects (group 2), and class III - 24 subjects (group 3). Clinical and laboratory data were assessed during a personal interview and review of medical records. On admission, all subjects were in New York Heart Association functional class I or II, had normal sinus rhythm and normal PR intervals. Exclusion criteria at initial enrollment were: any degree of atrioventricular block or non-sinus rhythm, previous documented acute coronary events (unstable angina or myocardial infarction), chronic obstructive pulmonary disease, rheumatic valvular heart disease, alcohol addiction, thyroid dysfunction or abnormal serum electrolytes. Treadmill stress test and/or coronary artery angiogram were indicated in selected subjects to rule out concomitant coronary artery disease. World Health Organization and Helsinki Treaty regulations reviewed in Venice (1983) were followed and all subjects provided informed consent to participate.

Clinical follow-up:

All subjects have been followed-up by the same team of physicians. Medical visits have been scheduled at the outpatient clinics in a three to six-month interval. Medications were prescribed at the discretion of the physician who performed the primary evaluation. Body weight varied <2 kg during follow-up, and serum potassium varied from 3.5 to 5 milliequivalent/L. Mild systemic arterial hypertension (systolic arterial pressure ranging from 140 mmHg and 155 mmHg, or diastolic arterial pressure ranging from 90 mmHg and 105 mmHg) was observed in 41% of the subjects and all received anti-hypertensive medication (converting enzyme inhibitors, diuretics, vasodilators and/or beta-blockers) at the discretion of the physician who performed the primary evaluation in order to reduce blood pressure levels to less than 140/90 mmHg. All regularly followed at scheduled clinical visits. The endpoints were described elsewhere in this registry. All causes of adverse events were ascertained by active search of relatives and review of the medical records.

Resting surface 12-lead ECG and plain chest roentgenogram

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Cardiac death [Time Frame: up to 10 years ]

时间窗: up tp 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.

次要结局

  • Ventricular tachycardia(up to ten years)
  • Persistent atrial fibrillation(up to 10 years)
  • Cardiac function and dimensions(up to 10 years)
  • Stroke, either fatal or nonfatal(up to 10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paulo Roberto Benchimol Barbosa

Head Researcher

Universidade Gama Filho

研究点 (4)

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