Stress Management in Patients With Coronary Artery Disease

Stress Management in Patients With Coronary Artery Disease: a Randomized Clinical Trial

Introduction: Stress can cause hemodynamic and metabolic changes that contribute to endothelial dysfunction and there is a significant association between high stress and cardiovascular events. Objective: To evaluate the influence of stress management on endothelial function in patients undergoing percutaneous coronary intervention (PCI). Methods: Randomized, controlled, parallel, intention-to-treat clinical trial. Will be considered eligible patients who underwent percutaneous coronary intervention and who have high stress (above average for the Brazilian population) in the Perceived Stress Scale (PSS-10). Patients will be evaluated on PCI admission and stress management with cognitive behavioral techniques will be implemented one month after hospital discharge in the intervention group. Group sessions will be held between 6-9 people. There will be 4 1-hour meetings for 8 weeks. The primary outcome will be the difference in the variation of brachial artery flow-mediated dilatation (FMD) between the groups and at 3 months of baseline evaluation and at 6-month follow-up after the intervention and the secondary outcome will be the difference in the variation of the velocity of brachial artery. Pulse wave evaluated at the same time periods as DMF. Outcomes will be evaluated by Generalized Estimation Equations (GEE). Expected Results: In patients undergoing high-stress percutaneous coronary intervention, the use of cognitive behavioral techniques for stress management will improve endothelial function and vascular stiffness.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stress, Psychological
• Intervention / Treatment: Behavioral: Management of Stress; Other: Usual care

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-000
      • Marcia Moura Schmidt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years;
• Patients with CAD - obstruction of one or more epicardial arteries with at least 70% stenosis and / or Left Coronary Trunk (TBI) with at least 50% - measured by catheterization (CATE) and having performed elective PCI
• High stress: above average score for the Brazilian population in the Perceived Stress Scale (PSS-10)
• Signing of the Informed Consent.

Exclusion Criteria:

• Age ≥ 80 years
• Patients with inpatient events (AMI, CABG, stroke)
• Indication of catheterization for valvulopathies or congenital heart disease
• Severe aortic stenosis / Ejection fraction <30%, cardiomyopathy, severe congestive heart disease
• Severe diseases with life expectancy <6 months
• Cognitive or mental difficulties to understand the instrument
• Inability to follow up visits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Intervention- Management of stress; Patients in the intervention group will receive usual medical care and more stress management intervention. Stress management with cognitive behavioral techniques will be implemented one month after hospital discharge in the intervention group. Group sessions will be held between 6-9 people. There will be 3 1-hour meetings for 3 weeks. The intervention will be performed by psychologist.	Behavioral: Management of Stress; Psychoeducation: Coronary artery disease, Percutaneous Coronary Intervention, traditional risk factors and emotional stress. Stress: physiology, triggers, triad (thinking, emotion, action). Skills training: Identify warning signs - signs and symptoms; Monitoring of irrational automatic thoughts generating alternative interpretations of situations or unrealistic thinking patterns (Dysfunctional Thinking Records Sheet). Self-control for stress management: Assertiveness training, problem solving. Thought-stopping technique, designed for dysfunctional thoughts, such as, "I won't do it," "It won't work." Stress Relief / Control Techniques: Diaphragmatic Breathing: Expansion of the abdomen rather than the chest when breathing. Progressive Muscle Relaxation: Maximize tension and alternately relax the muscles (legs, abdomen, chest, arms and face).
Active Comparator: Group Control; Patients in the control group will receive usual medical care.	Other: Usual care; outpatient medical appointments; Other Names: Patients in the control group will receive usual medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto de Cardiologia do Rio Grande do Sul
• Investigators: Study Director: Marcia Moura Schmidt, PhD, Instituto de Cardiologia do Rio Grande do Sul; Principal Investigator: Karine Elisa Schwarzer Schmidt, Instituto de Cardiologia do Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): January 5, 2023
• Study Completion (Estimated): October 5, 2023

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention;; Stress, Psychological;; Coronary Artery Disease;; Endothelium
• Additional Relevant MeSH Terms: Behavioral Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Stress, Psychological
• Other Study ID Numbers: UP 5648/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No