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Stress Management in Patients With Coronary Artery Disease

Primary Purpose

Stress, Psychological

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Management of Stress
Usual care
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring Stress, Psychological;, Coronary Artery Disease;, Percutaneous Coronary Intervention;, Endothelium;

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Marcia Moura Schmidt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group Intervention- Management of stress

Group Control

Arm 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.

Patients in the control group will receive usual medical care.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
January 8, 2020
Last Updated
June 28, 2023
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT04223882
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
January 5, 2023 (Actual)
Study Completion Date
October 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
Stress, Psychological;, Coronary Artery Disease;, Percutaneous Coronary Intervention;, Endothelium;

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Intervention- Management of stress
Arm Type
Experimental
Arm 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.
Arm Title
Group Control
Arm Type
Active Comparator
Arm Description
Patients in the control group will receive usual medical care.
Intervention Type
Behavioral
Intervention Name(s)
Management of Stress
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Usual care
Other Intervention Name(s)
Patients in the control group will receive usual medical care
Intervention Description
outpatient medical appointments
Primary Outcome Measure Information:
Title
Difference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment.
Description
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).
Time Frame
Three months after the first evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcia Moura Schmidt, PhD
Organizational Affiliation
Instituto de Cardiologia do Rio Grande do Sul
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Karine Elisa Schwarzer Schmidt
Organizational Affiliation
Instituto de Cardiologia do Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marcia Moura Schmidt
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90620-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Stress Management in Patients With Coronary Artery Disease

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