NCT02868216

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Status
completed

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

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

November 5, 2019

Completed
Last Updated

June 29, 2023

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

August 11, 2016

Results QC Date

October 25, 2018

Last Update Submit

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

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.

Behavioral: anger management training

Without management training

NO INTERVENTION

No anger management training

Interventions

anger management training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Anger Management Therapy

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

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

  • Marcia Moura Schmidt, PhD

    Instituto de Cardiologia do Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

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
Model Details: One group receives training for anger management, with guidance on infarction and physiology of anger and another group, does not receive.
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