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Myocardial InfarctionMAPAMINCT02868216

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

A study testing anger management training in people with Myocardial Infarction, run by Instituto de Cardiologia do Rio Grande do Sul.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Myocardial Infarction
What is being tested?
anger management training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
15 Sep 2015to 15 Jul 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • acute st elevation myocardial infarction

Who cannot join

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

About this study

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

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.

Read more

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.

Read the 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.

Being tested
anger management training
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anger management trainingBehavioural

Study groups in NCT02868216
Study groupRoleWhat they receive
anger management trainingExperimentaltreatment 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.
Receives: Behavioral: anger management training
Without management trainingNo interventionNo anger management training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: three months after the first evaluation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2016 (estimated)
  2. Study start15 Sep 2015
  3. Primary completion1 Mar 2016
  4. Study completion15 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
One group receives training for anger management, with guidance on infarction and physiology of anger and another group, does not receive.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02868216
Sponsor's protocol ID
UP4985/14
Acronym
MAPAMI
Status last verified
Sep 2019
First submitted
11 Aug 2016
Last updated
29 Jun 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34840289

Questions about this trial

What is this clinical trial studying?

A study testing anger management training in people with Myocardial Infarction, run by Instituto de Cardiologia do Rio Grande do Sul.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment. (time frame: three months after the first evaluation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02868216, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.

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