Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02868216 |
| Other study ID # |
UP4985/14 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2015 |
| Est. completion date |
July 15, 2017 |
Study information
| Verified date |
September 2019 |
| Source |
Instituto de Cardiologia do Rio Grande do Sul |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
ANGER TREATMENT:
session 1 -Participants are asked what usually makes them angry. The "triggers" of anger are
identified; the relationship between rabies and cardiovascular physiology is explained.
According to Lipp and Malagris19 (p.115), "anger changes the way the body works, changes
breathing, pressure increases, etc. When a person feels anger, the physical reaction that
occurs is automatic and unplanned, it is difficult control, but the identification of
triggers before the emotion sets in, will help to prevent it. Identifying and understanding
anger in three dimensions: cognitive, emotional, and behavioral Think before acting Behavior
is the final step, which you do not need be damaging.
Session 2 - Participants are reminded of "elicitor rabies events". Investigate the situations
that felt anger during the month and what they thought. To point out how the cognitions, that
is, how one interprets the facts of life leads to different emotions. How anger behavior is
directly linked to the interpretations people give to events; It is important to improve the
way you evaluate events and the world around you. Closing: Deep Breathing Exercise Technical
Time-Out: isolate yourself from the situation that generates anger to take control.
The control group patients will not receive any anger managementtraining.
STATISTICAL ANALYSIS
The minimum sample size was calculated in 88 patients to detect a 1% difference in
flow-mediated dilation between the two study groups, with an average standard deviation of
1.67%, p <0.05 and statistical power of 90 %. The data are presented as means and confidence
intervals (95% CIs), unless otherwise specified. All analyzes will be based on the principle
of intention to treat, and will be conducted by researchers who do and whether or not the
cognitive training for control of anger. Repeated measures of analysis of variance will be
performed to determine differences in flow-mediated dilation (primary endpoint) and all
secondary outcomes between the two groups over time, using a conservative F test for the
interaction between time and study group ( SPSS software, version 18).
The Geisser correction for the F test is used to adjust the degrees of freedom for the
roundness deviation (one of the conditions of the repeated measures analysis of variance
[ANOVA]). logarithmic transformation of the data will be undertaken as appropriate. Fisher's
post hoc analysis for unpaired and paired data will be performed and interpreted using the
Bonferroni-Holm adjustment for multiple comparisons.
The post correlation hoc analysis (by the Spearman rank-correlation method) will be performed
to evaluate the relationship between the change in flow-mediated dilation of the baseline to
3 months and the changes in the anger control scores assessed by STAXI from the beginning up
to 3 months. Differences between categorical variables are calculated using the chi-square
test. A value of P-tailed <0.05 is considered to indicate statistical significance.
