Stress Management in Patients With Coronary Artery Disease

Instituto de Cardiologia do Rio Grande do Sul

Status: Invitation-only

Conditions: Stress, Psychological

Treatments: Other: Usual care; Behavioral: Management of Stress

Study type: Interventional

Funder types: Other

Identifiers

NCT04223882

UP 5648/19

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Group Intervention- Management of stress

Experimental group

Description:

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.

Treatment:

Behavioral: Management of Stress

Group Control

Active Comparator group

Description:

Patients in the control group will receive usual medical care.

Treatment:

Other: Usual care