Stress Management in Patients With Coronary Artery Disease

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04223882
• Other study ID #: UP 5648/19
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: October 5, 2023

Study information

• Verified date: June 2023
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: October 5, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stress, Psychological

Intervention

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).

Other:
• Usual care
outpatient medical appointments

Locations

Country	Name	City	State
Brazil	Marcia Moura Schmidt	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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