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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
anger management training
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    anger management training

    Without management training

    Arm Description

    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.

    No anger management training

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    August 11, 2016
    Last Updated
    June 28, 2023
    Sponsor
    Instituto de Cardiologia do Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02868216
    Brief Title
    Management of Anger in Patients With Acute Myocardial Infarction (MAPAMI)
    Acronym
    MAPAMI
    Official Title
    Management of Anger in Patients With ST Segment Elevation Acute Myocadial Infarction: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 15, 2015 (Actual)
    Primary Completion Date
    March 1, 2016 (Actual)
    Study Completion Date
    July 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto de Cardiologia do Rio Grande do Sul

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    One group receives training for anger management, with guidance on infarction and physiology of anger and another group, does not receive.
    Masking
    Outcomes Assessor
    Masking Description
    Blinding occurs only in relation to the evaluator of endothelial function
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    anger management training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Without management training
    Arm Type
    No Intervention
    Arm Description
    No anger management training
    Intervention Type
    Behavioral
    Intervention Name(s)
    anger management training
    Primary Outcome Measure Information:
    Title
    Difference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment.
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marcia Moura Schmidt, PhD
    Organizational Affiliation
    Instituto de Cardiologia do Rio Grande do Sul
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34840289
    Citation
    Schmidt KES, de Quadros AS, Eibel B, Aires AM, Gottschall CAM, Moura MRS, Schmidt MM. The Influence of Cognitive Behavioral Intervention for Anger Management on Endothelial Function in Patients With Recent Myocardial Infarction: A Randomized Clinical Trial. Psychosom Med. 2022 Feb-Mar 01;84(2):224-230. doi: 10.1097/PSY.0000000000001039.
    Results Reference
    derived

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

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