Heart-brain-axis and Psychosocial Stress

NCT06345573 | Active Not Recruiting

• 1 other identifier: BASEC 2020-02922
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The main study objective is to prospectively determine the influence of sex-related risk factors and psychosocial variables on neuronal stress responses and myocardial perfusion in a population of 64 female and male individuals 50-75 years of age and free of cardiovascular disease.

Conditions

Mental Stress; Myocardial Ischemia; Sex Role; Gender

Outcome Measures

Primary Outcomes (3)

• Amygdala-to-cerebellum ratio of glycolytic metabolic activities (SUV/SUV)

  Sex differences in the stress-related neural activity (SNA) assessed by 18F-FDG-PET and defined as the amygdala metabolic activity (AmygA, expressed as standard uptake value, SUV) corrected to the metabolic activity of the cerebellum (expressed as SUV), following the Trier Social Stress Test. The higher the AmygA/(cerebellum activity) ratio, the higher the SNA (no threshold for normality)

  11-10-2021 to 20-11-2023

• Difference between the rest and stress amygdala-to-cerebellum perfusion ratios (kBq/kBq)

  Sex differences in the amygdala perfusion between rest and stress, assessed by 13N-NH3-PET and defined as the amygdala perfusion (AmygP, expressed as kiloBecquerel, kBq) corrected to the perfusion of the cerebellum (expressed as kBq), following the Montreal Imaging Stress Task. The higher the magnitude of the AmygP/(Cerebellum perfusion) modification at stress compared to rest, the higher the amygdala response to mental stress (no threshold for normality)

  11-10-2021 to 20-11-2023

• Myocardial flow reserve (MFR, no unit)

  Sex differences in myocardial flow reserve (MFR) as determined by 13N-NH3-PET, during the Montreal Imaging Stress Task. MFR is defined as the ratio between MBF at stress and MBF at rest (no unit). The higher the MFR, the higher the myocardial perfusion modification during the stress task (no threshold).

  11-10-2021 to 20-11-2023

Secondary Outcomes (24)

• Amygdala-to-vmPFC ratio of glycolytic metabolic activities (SUV/SUV)

  11-10-2021 to 20-11-2023

• Difference between the rest and stress amygdala-to-vmPFC perfusion ratios (kBq/kBq)

  11-10-2021 to 20-11-2023

• Myocardial blood flow (MBF) at rest (mL/g/min)

  11-10-2021 to 20-11-2023

• Myocardial blood flow (MBF) at stress (mL/g/min)

  11-10-2021 to 20-11-2023

• Heart-rate response (HRR, no unit)

  11-10-2021 to 20-11-2023

Other Outcomes (20)

• Rate-Pressure-Product (RPP, in beats per minute x mmHg)

  11-10-2021 to 20-11-2023

• vmPFC-to-cerebellum ratio of glycolytic metabolic activities (SUV/SUV)

  11-10-2021 to 20-11-2023

• Nail cortisol value (pg/mg)

  11-10-2021 to 20-11-2023

Study Arms (2)

Female Sex

Healthy volunteer women aged between 50-75 years old, in post-menopausal status.

Behavioral: Mental stress

Male Sex

Healthy volunteer men aged between 50-75 years old.

Behavioral: Mental stress

Interventions

Mental stress BEHAVIORAL

Two consecutive validated mental stress tests, namely 1) the Montreal Imaging Stress Task consisting of two series of 15-minute mental calculation tests, without (Control Mode) and with (Stress Mode) negative feedback, respectively; and 2) the Trier Social Stress Test consisting of a 5-minute mock job interview (Speech Part) followed by a 5-minute mental calculation test (Mental Arithmetic Part).

Female Sex; Male Sex

Eligibility Criteria

• Age: 50 Years - 75 Years
• Gender Eligibility Details: We recruited healthy male and female volunteers, and gender identity was additionnally assessed using a gender score.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We included healthy volunteers aged between 50-75 years old, post-menopausal in the case of women, recruited mainly in Switzerland.

You may qualify if:

• Women and men that are between 50-75 years of age
• Post-menopausal status in women
• Normal body weight (BMI\<30kg/m2)
• Non-smoker or not smoking since ≥ 5 years or occasional smokers.

You may not qualify if:

• Written informed consent was not provided
• History of arterial hypertension
• History of diabetes
• History of cardiovascular disease
• History of neurological disorders
• History of cancer (unless considered in remission since at least 5 years and not having necessitated a systemic chemotherapy and/or a brain radiotherapy)
• Use of steroids interfering with biomarker levels

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Stress, Psychological; Myocardial Ischemia; Coitus

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Sexual Behavior

Study Officials

• Cathérine Gebhard, Professor

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: April 3, 2024
• Study Start: October 11, 2021
• Primary Completion: November 20, 2023
• Study Completion: November 1, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

CH (1)