跳至主要内容
临床试验/NCT02868216
NCT02868216已完成不适用

Management of Anger in Patients With ST Segment Elevation Acute Myocadial Infarction: A Randomized Clinical Trial

Instituto de Cardiologia do Rio Grande do Sul0 个研究点目标入组 90 人开始时间: 2015年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
主要终点
Difference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment.

研究概览

简要总结

Stress, anger and depressed can operate as a trigger to an Acute Coronary Syndrome. It is often found in the literature that patients refer excessive anger, anxiety, sadness, pain or acute stress before the acute myocardial infarction (AMI). Moreover, a recent meta-analysis reported a strong association between the occurrence of AMI and many of these acute emotions.

Anger is a common manifestation of psychological stress and could trigger off an atherogenic process through several mechanisms.

Coronary atherosclerosis features narrowing of coronary arteries on account of endothelial thickening caused by the build up of atheromatous plaques. It is a process characterized by inflammatory and fibroproliferative response of the artery wall, caused by continuous aggression to its surface and whose thickening, evoked by the evolution of fat streaks atherosclerotic lesions, until fiber plaques is quite slow. Endothelial dysfunction also results in the loss of natural anti-thrombotic properties involved in the endothelium patency.

According to a study performed by our group, anger management was significantly lower among patients with CAD when compared to those without CAD, and the occurrence of major cardiovascular events (MACE) was significantly higher in patients presented with lower anger control. Both associations were independent from traditional risk factors, occurrence of previous events or another anger aspects. Thus, this study was designed in order to evaluate the effect of the "cognitive training to anger management " on endothelium-dependent vasodilation of the arm artery in patients with acute myocardial infarction with ST segment elevation submitted to primary coronary intervention.

详细描述

ANGER EVALUATION:

Anger will be assessed by the Spielberger State-Trait Anger Expression Inventory (STAXI). This instrument was developed to evaluate the expression of anger components and their role in a variety of medical conditions. These are statements to be assessed on a Likert scale of 4 points. Individuals are asked about the intensity of his anger, and how often experience this emotion.

The anger trait measures individual differences in willingness to experience anger. It is evaluated through 10 questions, with their scores between 10 and 40 points. It is divided in temperament and anger reaction. Anger expression provides a general index on the frequency with which anger is experienced, expressed, suppressed or controlled and is evaluated with three subscales: anger inside, when angry feelings are repressed or stored; anger-out, when the individual expresses anger toward other persons or objects in the environment; and anger management (control) which measures the frequency with which each individual tries to control the expression of raiva. Each of these subscales is assessed by eight questions, ranging from 32 to 64 points. The total score for the expression of anger is evaluated by the results: Total + in total off - control +16.

Randomization All patients were evaluated during hospitalization for AMI, but only those anger control score were less than 27 points were invited to participate. A randomization list was obtained by random.org site and were generated sequential envelopes, sealed and numbered which were opened in order day in assessment of endothelial function.

Endothelial function Endothelial dysfunction is an early dysfunctional vascular responses observed in tissue prone to develop atherosclerosis and is also associated with vessel with atherosclerosis in later stages. The evaluation of endothelial function will be performed by researchers "blinded" as to treatment group. The endothelium-dependent vasodilation of the brachial artery will be evaluated by ultrasound with a linear transducer 3-12 MHz (EnVisor CHD, Philips, Bothell, WA, USA), being held automated measurements of vessel diameter to own the equipment used software. The evaluations will be conducted in the mornings after fasting for 12 hours under controlled temperature (22 ° C). After ten minutes of images of the brachial artery rest will be recorded with the linear transducer placed above the antecubital fossa continuously for one minute (basal). The sphygmomanometer is placed on the arm and inflated up to 50 mmHg limit above systolic blood pressure for five minutes, and the change in diameter of the brachial artery after 60 seconds of cuff deflation will be compared with the basal diameter. The images of the vessel diameter at end-diastole (identified by R wave of the ECG) will be digitized and recorded at intervals of 3 seconds throughout the procedure, and subsequently analyzed off-line using software itself equipamento41.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Blinding occurs only in relation to the evaluator of endothelial function

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
否

入选标准

  • •acute st elevation myocardial infarction

排除标准

  • •dementia, cognitive dysfunction,
  • •bypass surgery previous or during the study periods living from more 200 Km from hospital

研究组 & 干预措施

anger management training

Experimental

treatment group- Two monthly sessions will address the events triggering anger, the physiology of anger and the influence on the cardiovascular system, the dimesions of anger: cognitive, emotional and behavioral.

干预措施: anger management training (Behavioral)

Without management training

No Intervention

No anger management training

结局指标

主要结局

Difference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment.

时间窗: three months after the first evaluation

Inter group difference in flow-mediated dilation in the brachial artery in the baseline and after the treatment (about Three months after the first). Vasodilatation of the endothelium-dependent brachial artery was evaluated by ultrasound using a 3-12 MHz linear transducer. Three images of the basal diameter (BD) of the brachial artery at the end of the diastole were acquired, as well as the mean velocity of the baseline arterial flow, with the linear transducer positioned 5 cm above the antecubital fossa. Subsequently, the sphygmomanometer was placed in the arm and inflated 50 mmHg above baseline systolic blood pressure for five minutes. After that, 3 images of the arterial diameter were acquired up to 80 seconds of the deflation of the cuff (post-occlusion diameter- PD), as well as the average of the arterial flow velocity. Flow-dependent vasodilation responses were expressed as a percentage variation from the baseline brachial diameter (PD-BD/ BD x 100).

次要结局

未报告次要终点

研究者

发起方
Instituto de Cardiologia do Rio Grande do Sul
申办方类型
Other
责任方
Sponsor

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