Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345573
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-05
Brief Title:
Heart-brain-axis and Psychosocial Stress
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Sex Differences in Heart-brain Crosstalk - Role of Psychosocial Stress
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The main objective of the project is to prospectively determine the influence of sex on amygdalar metabolic activity and myocardial perfusion in a population of healthy postmenopausal women and aged men under acute psychosocial stress conditions
The primary hypothesis of the study is that women experience disproportionate amygdalar metabolic activity and reduced myocardial perfusion in response to psychosocial stress compared to men
This project is a monocentric prospective observational study involving hybrid positron emission tomographymagnetic resonance PETMR imaging as well as the collection of biological samples in healthy individuals aged 50-75 years postmenopausal women and men To inflict acute psychosocial stress the investigators applied the Montreal Imaging Stress Test MIST when the participants were inside the PETMR scanner and the Trier Social Stress Test TSST when the participants were outside the PETMR scanner Both the TSST and the MIST are standardized tests and are widely applied to provoke reliable biological stress responses in a laboratory setting No follow-up study is planned At inclusion individuals have been interviewed and health data have been collected through questionnaires In addition biological samples including blood nail and saliva have been collected Volunteers underwent myocardial blood flow MBF and cerebral perfusion imaging using ammonia 13NH3-PET as well as functional imaging using magnetic resonance imaging MRI both routinely used imaging techniques 13NH3-PETMR has been conducted at rest and under stress MIST Subsequently the study participants underwent a TSST followed by whole body metabolic imaging with fluor-18-deoxyglucose 18F-FDG-PETMRI allowing to study brain and bone marrow metabolism among other parameters In parallel the heart rate response HRR has been monitored throughout the study and catecholamines were collected at baseline and after stress to assess the autonomic influence on the heart The total radiation exposure was below 5 mSv
In detail each participant was asked to complete questionnaires to assess their psychometric baseline characteristics at the study visit
Two blood samples were collected from a peripheral intravenous catheter at the beginning of the study and the end of the TSST Blood glucose levels were measured using a finger prick In addition saliva samples of approximately 1 mL each were taken at different time points notably before and after each of the mental stress tests Nail samples were collected by clipping nails from the fingers andor toes
All biological samples from the participants were immediately processed to allow sample conservation
Project data and samples were handled with the uttermost discretion and only accessible to authorized personnel On project-specific documents participants are only identified by a unique participant number Coded data were used and the participant identification list is only accessible by the investigators Data is protected from unauthorized or accidental disclosure alteration deletion copying and theft by using the built-in mechanisms of Redcap Biological material in this project is not identified by participant name but by a unique participant number
Participants were asked to fast for at least 25 hours prior to the study visit and refrain from strong physical activity for at least 24 hours All study participants underwent serial imaging on a dedicated hybrid PETMR scanner GE Healthcare using 13N-NH3 and 18F-FDG as validated tracers according to daily clinical routine Whole-body 18F-FDG or brain and heart 13-NH3 MRI were recorded simultaneously with all PET scan acquisitions Beginning with an intravenous bolus administration of 200 MBq of 13N-NH3 serial dynamic and static PET images were acquired for 30 minutes In parallel subjects underwent the Control rest part of the MIST mathematical task inside the scanner A second dose of 400 MBq of 13N-NH3 was given and images were recorded in the same acquisition sequence for 30 minutes in parallel to the Stress part of the MIST
After a break all individuals were injected with 150 MBq of 18F-FDG followed by a TSST outside of the scanner During the first part of the TSST a panel of two to three judges trained staff equipped with a video camera ask the participant to prepare a 5-minute presentation To do that participants can use paper and pen but must hand out their notices at the beginning of the presentation During the 5-minute presentation the judges observe the participants without giving any comments or facial expressions The participants are asked to continue if they stop before the entire 5 minutes run out For the second part of the TSST participants undergo a mental arithmetic task during which they are asked to count backward from 1022 in steps of 11 Subsequently participants were allowed to rest in a designated separate dark room rest phase and the 18F-FDG-PET scan was performed ca 60 min after tracer injection to assess metabolic activity in the brain according to routine procedures at the Department of Nuclear Medicine of the University Hospital Zurich Heart rate and blood pressure were recorded at baseline and throughout the procedure
The procedure from the initial scan to the end of the final scan takes about 35 hours Together with the 2 hours of preparation participants spent about 55 hours on the study in total
The primary hypothesis of the study is that women experience disproportionate amygdalar metabolic activity and reduced myocardial perfusion in response to psychosocial stress compared to men
This project is a monocentric prospective observational study involving hybrid positron emission tomographymagnetic resonance PETMR imaging as well as the collection of biological samples in healthy individuals aged 50-75 years postmenopausal women and men To inflict acute psychosocial stress the investigators applied the Montreal Imaging Stress Test MIST when the participants were inside the PETMR scanner and the Trier Social Stress Test TSST when the participants were outside the PETMR scanner Both the TSST and the MIST are standardized tests and are widely applied to provoke reliable biological stress responses in a laboratory setting No follow-up study is planned At inclusion individuals have been interviewed and health data have been collected through questionnaires In addition biological samples including blood nail and saliva have been collected Volunteers underwent myocardial blood flow MBF and cerebral perfusion imaging using ammonia 13NH3-PET as well as functional imaging using magnetic resonance imaging MRI both routinely used imaging techniques 13NH3-PETMR has been conducted at rest and under stress MIST Subsequently the study participants underwent a TSST followed by whole body metabolic imaging with fluor-18-deoxyglucose 18F-FDG-PETMRI allowing to study brain and bone marrow metabolism among other parameters In parallel the heart rate response HRR has been monitored throughout the study and catecholamines were collected at baseline and after stress to assess the autonomic influence on the heart The total radiation exposure was below 5 mSv
In detail each participant was asked to complete questionnaires to assess their psychometric baseline characteristics at the study visit
Two blood samples were collected from a peripheral intravenous catheter at the beginning of the study and the end of the TSST Blood glucose levels were measured using a finger prick In addition saliva samples of approximately 1 mL each were taken at different time points notably before and after each of the mental stress tests Nail samples were collected by clipping nails from the fingers andor toes
All biological samples from the participants were immediately processed to allow sample conservation
Project data and samples were handled with the uttermost discretion and only accessible to authorized personnel On project-specific documents participants are only identified by a unique participant number Coded data were used and the participant identification list is only accessible by the investigators Data is protected from unauthorized or accidental disclosure alteration deletion copying and theft by using the built-in mechanisms of Redcap Biological material in this project is not identified by participant name but by a unique participant number
Participants were asked to fast for at least 25 hours prior to the study visit and refrain from strong physical activity for at least 24 hours All study participants underwent serial imaging on a dedicated hybrid PETMR scanner GE Healthcare using 13N-NH3 and 18F-FDG as validated tracers according to daily clinical routine Whole-body 18F-FDG or brain and heart 13-NH3 MRI were recorded simultaneously with all PET scan acquisitions Beginning with an intravenous bolus administration of 200 MBq of 13N-NH3 serial dynamic and static PET images were acquired for 30 minutes In parallel subjects underwent the Control rest part of the MIST mathematical task inside the scanner A second dose of 400 MBq of 13N-NH3 was given and images were recorded in the same acquisition sequence for 30 minutes in parallel to the Stress part of the MIST
After a break all individuals were injected with 150 MBq of 18F-FDG followed by a TSST outside of the scanner During the first part of the TSST a panel of two to three judges trained staff equipped with a video camera ask the participant to prepare a 5-minute presentation To do that participants can use paper and pen but must hand out their notices at the beginning of the presentation During the 5-minute presentation the judges observe the participants without giving any comments or facial expressions The participants are asked to continue if they stop before the entire 5 minutes run out For the second part of the TSST participants undergo a mental arithmetic task during which they are asked to count backward from 1022 in steps of 11 Subsequently participants were allowed to rest in a designated separate dark room rest phase and the 18F-FDG-PET scan was performed ca 60 min after tracer injection to assess metabolic activity in the brain according to routine procedures at the Department of Nuclear Medicine of the University Hospital Zurich Heart rate and blood pressure were recorded at baseline and throughout the procedure
The procedure from the initial scan to the end of the final scan takes about 35 hours Together with the 2 hours of preparation participants spent about 55 hours on the study in total
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None