Ignite Creation Date:
2024-05-06 @ 8:58 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02868216
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2016-08-11
Brief Title:
Management of Anger in Patients With Acute Myocardial Infarction MAPAMI
Sponsor:
Instituto de Cardiologia do Rio Grande do Sul
Organization:
Instituto de Cardiologia do Rio Grande do Sul
Study Overview
Official Title:
Management of Anger in Patients With ST Segment Elevation Acute Myocadial Infarction A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAPAMI
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
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 randomorg 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 p115 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 167 p 005 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 Fishers 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 005 is considered to indicate statistical significance
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 randomorg 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 p115 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 167 p 005 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 Fishers 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 005 is considered to indicate statistical significance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None