Clinical trial NCT04223882: Stress Management in Patients With Coronary Artery Disease
Official title: Stress Management in Patients With Coronary Artery Disease: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Keywords: Stress, Psychological;
Coronary Artery Disease;
Percutaneous Coronary Intervention;
Endothelium;
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment.
timeFrame: Three months after the first evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Marcia Moura Schmidt
state: Rio Grande Do Sul
Study officials:
affiliation: Instituto de Cardiologia do Rio Grande do Sul
name: Marcia Moura Schmidt, PhD
role: STUDY_DIRECTOR
affiliation: Instituto de Cardiologia do Rio Grande do Sul
name: Karine Elisa Schwarzer Schmidt
role: PRINCIPAL_INVESTIGATOR
References: