Trial Outcomes & Findings for Management of Anger in Patients With Acute Myocardial Infarction (MAPAMI) (NCT NCT02868216)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

three months after the first evaluation

Results posted on

2023-06-29

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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	Without Management Training No anger management training
Overall Study STARTED	43	47
Overall Study COMPLETED	35	41
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Without Management Training No anger management training
Overall Study Death	0	1
Overall Study coronary artery bypass	1	0
Overall Study Withdrawal by Subject	7	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anger Management Training n=35 Participants 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	Without Management Training n=41 Participants No anger management training	Total n=76 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 9 • n=5 Participants	58 years STANDARD_DEVIATION 10 • n=7 Participants	57 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	32 Participants n=7 Participants	59 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	29 Participants n=5 Participants	36 Participants n=7 Participants	65 Participants n=5 Participants
Race/Ethnicity, Customized Race · Afro-descendant	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Brazil	35 Participants n=5 Participants	41 Participants n=7 Participants	76 Participants n=5 Participants

PRIMARY outcome

Timeframe: three months after the first evaluation

Population: means and standard deviations after 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).

Outcome measures

Outcome measures
Measure	Anger Management Training n=35 Participants 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	Without Management Training n=41 Participants No anger management training
Difference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment.	11.24 percent change dilatation Standard Deviation 5.10	7.70 percent change dilatation Standard Deviation 4.40

Adverse Events

Intervention

Serious events: 5 serious events

Other events: 2 other events

Deaths: 2 deaths

Controls

Serious events: 2 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Intervention n=33 participants at risk Major adverse cardiovascular events: totally of death, myocardial infarction, percutaneous coronary intervention in intervention group	Controls n=39 participants at risk Major adverse cardiovascular events: totally of death, myocardial infarction, percutaneous coronary intervention in control group
Cardiac disorders Major adverse Cardiovascular events	15.2% 5/33	5.1% 2/39

Other adverse events

Other adverse events
Measure	Intervention n=33 participants at risk Major adverse cardiovascular events: totally of death, myocardial infarction, percutaneous coronary intervention in intervention group	Controls n=39 participants at risk Major adverse cardiovascular events: totally of death, myocardial infarction, percutaneous coronary intervention in control group
Cardiac disorders Percutaneous coronary intervention	6.1% 2/33	2.6% 1/39

Additional Information

Dra Marcia Moura Schmidt

Cardiologia (Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology

Phone: 5551 32333600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place