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Management of Anger in Patients With Acute Myocardial Infarction (MAPAMI)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02868216
Acronym
MAPAMI
Enrollment
90
Registered
2016-08-16
Start date
2015-09-15
Completion date
2017-07-15
Last updated
2023-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Brief 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.

Detailed 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.

Interventions

BEHAVIORALanger management training

Sponsors

Instituto de Cardiologia do Rio Grande do Sul
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Blinding occurs only in relation to the evaluator of endothelial function

Intervention model description

One group receives training for anger management, with guidance on infarction and physiology of anger and another group, does not receive.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

acute st elevation myocardial infarction

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment.three months after the first evaluationInter 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).

Participant flow

Recruitment details

dates of the recruitment: 09/15/2015 to 07/15/2017 patients with AMY in this period: 707

Pre-assignment details

Patients submitted to myocardial revascularization surgery, with acute or chronic infections, need for mechanical ventilation or other complications were excluded; those with delirium, cognitive or mental difficulties, aged ≥ 80 years; and also, unable to comply with follow-up visits or who refused to participate.

Participants by arm

ArmCount
Anger Management Training
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. anger management training
35
Without Management Training
No anger management training
41
Total76

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studycoronary artery bypass10
Overall StudyDeath01
Overall StudyWithdrawal by Subject75

Baseline characteristics

CharacteristicAnger Management TrainingWithout Management TrainingTotal
Age, Continuous56 years
STANDARD_DEVIATION 9
58 years
STANDARD_DEVIATION 10
57 years
STANDARD_DEVIATION 10
Race/Ethnicity, Customized
Race
Afro-descendant
6 Participants5 Participants11 Participants
Race/Ethnicity, Customized
Race
Caucasian
29 Participants36 Participants65 Participants
Region of Enrollment
Brazil
35 Participants41 Participants76 Participants
Sex: Female, Male
Female
8 Participants9 Participants17 Participants
Sex: Female, Male
Male
27 Participants32 Participants59 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 331 / 39
other
Total, other adverse events
2 / 331 / 39
serious
Total, serious adverse events
5 / 332 / 39

Outcome results

Primary

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

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).

Time frame: three months after the first evaluation

Population: means and standard deviations after treatment

ArmMeasureValue (MEAN)Dispersion
Anger Management TrainingDifference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment.11.24 percent change dilatationStandard Deviation 5.1
Without Management TrainingDifference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment.7.70 percent change dilatationStandard Deviation 4.4
p-value: 0.0595% CI: [0.63, 3.98]ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026