Management of Anger in Patients With Acute Myocardial Infarction (MAPAMI)
MAPAMI
1 other identifier
interventional
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 11, 2016
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2017
CompletedResults Posted
Study results publicly available
November 5, 2019
CompletedJune 29, 2023
September 1, 2019
6 months
August 11, 2016
October 25, 2018
June 28, 2023
Conditions
Outcome Measures
Primary Outcomes (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).
three months after the first evaluation
Study Arms (2)
anger management training
EXPERIMENTALtreatment 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 INTERVENTIONNo anger management training
Interventions
Eligibility Criteria
You may qualify if:
- acute st elevation myocardial infarction
You may not qualify if:
- dementia, cognitive dysfunction,
- bypass surgery previous or during the study periods living from more 200 Km from hospital
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 34840289DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dra Marcia Moura Schmidt
- Organization
- Cardiologia (Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology
Study Officials
- PRINCIPAL INVESTIGATOR
Marcia Moura Schmidt, PhD
Instituto de Cardiologia do Rio Grande do Sul
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Blinding occurs only in relation to the evaluator of endothelial function
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2016
First Posted
August 16, 2016
Study Start
September 15, 2015
Primary Completion
March 1, 2016
Study Completion
July 15, 2017
Last Updated
June 29, 2023
Results First Posted
November 5, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share