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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Myocardial Infarction
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: anger management training |
| Without management training | No intervention | No anger management training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted16 Aug 2016 (estimated)
- Study start15 Sep 2015
- Primary completion1 Mar 2016
- Study completion15 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcia Moura Schmidt, PhD, Principal investigator, Instituto de Cardiologia do Rio Grande do Sul
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Anger in Patients With ST Segment Elevation Acute Myocadial Infarction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02868216
- Acronym / sponsor ID
- MAPAMI / UP4985/14
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Posted 5 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- One group receives training for anger management, with guidance on infarction and physiology of anger and another group, does not receive.
| Arm | Type | Receives |
|---|---|---|
| anger management training | Experimental | Behavioral: anger management trainingtreatment 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. |
| Without management training | No intervention | –No anger management training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute st elevation myocardial infarction
Key exclusion criteria (2 listed)
- dementia, cognitive dysfunction,
- bypass surgery previous or during the study periods living from more 200 Km from hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anger management training | Behavioural | anger management training |
Primary outcome
Difference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment.
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34840289Schmidt 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.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia Moura Schmidt, PhD principal investigator
Instituto de Cardiologia do Rio Grande do Sul
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.