Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02621216
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2015-12-01
Brief Title:
Tilburg Health Outcomes Registry of Emotional Stress in Coronary Intervention
Sponsor:
Tilburg University
Organization:
Tilburg University
Study Overview
Official Title:
Tilburg Health Outcomes Registry of Emotional Stress in Coronary Intervention
Status:
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:
THORESCI
Brief Summary:
Background of the study
Percutaneous coronary interventions PCI have become mainstay treatment for acute coronary artery disease and the number of patients receiving PCI is vastly growing However relatively little long-term follow-up studies of large real-world clinical samples exist that have looked at the real-world effects of PCI treatment and adherence to current guidelines
Psychological risk factors are important in determining prognosis after PCI and undergoing PCI may increase the risk of low mood To date studies have examined single psychological risk factors without taking into account their relatedness Moreover guidelines are advocating psychosocial screening in early cardiovascular disease but the screening test as proposed in the prevention guideline has not yet been validated or tested Although the detrimental effects of psychological risk factors on cardiovascular prognosis are known the mechanisms through which they exert these effects are yet unclear It is to be expected that not one but multiple biological inflammation endothelial dysfunction and behavioural coping styles poor self-care consultation behaviour pathophysiological processes play a role and that these processes interact with each other In PCI patients the mechanisms linking psychological risk to poor prognosis are still to be investigated
Objective of the study
1 To examine the adherence to the prevention and PCI guidelines and the effects thereof on long term prognosis in PCI patients
2 To evaluate the effectiveness of the psychosocial screening instrument of the European Society of Cardiology Prevention guideline 2012
3 To examine effects of clustering psychological risk factors on several networks of potentially mediating mechanisms and long term outcomes in a large sample of PCI patients
Percutaneous coronary interventions PCI have become mainstay treatment for acute coronary artery disease and the number of patients receiving PCI is vastly growing However relatively little long-term follow-up studies of large real-world clinical samples exist that have looked at the real-world effects of PCI treatment and adherence to current guidelines
Psychological risk factors are important in determining prognosis after PCI and undergoing PCI may increase the risk of low mood To date studies have examined single psychological risk factors without taking into account their relatedness Moreover guidelines are advocating psychosocial screening in early cardiovascular disease but the screening test as proposed in the prevention guideline has not yet been validated or tested Although the detrimental effects of psychological risk factors on cardiovascular prognosis are known the mechanisms through which they exert these effects are yet unclear It is to be expected that not one but multiple biological inflammation endothelial dysfunction and behavioural coping styles poor self-care consultation behaviour pathophysiological processes play a role and that these processes interact with each other In PCI patients the mechanisms linking psychological risk to poor prognosis are still to be investigated
Objective of the study
1 To examine the adherence to the prevention and PCI guidelines and the effects thereof on long term prognosis in PCI patients
2 To evaluate the effectiveness of the psychosocial screening instrument of the European Society of Cardiology Prevention guideline 2012
3 To examine effects of clustering psychological risk factors on several networks of potentially mediating mechanisms and long term outcomes in a large sample of PCI patients
Detailed Description:
Rationale Percutaneous coronary interventions PCI have become mainstay treatment for acute coronary artery disease and the number of patients receiving PCI is vastly growing Clinical trials have reported on the efficacy and effects on quality of life and mortality Guidelines have been constructed for PCI treatment as well as cardiovascular prevention However relatively little long-term follow-up studies of large real-world clinical samples exist that have looked at the real-world effects of PCI treatment and adherence to current guidelines
Moreover psychological risk factors are important in determining prognosis after PCI and undergoing PCI may increase the risk of low mood To date studies have examined single psychological risk factors without taking into account their relatedness Moreover guidelines are advocating psychosocial screening in early cardiovascular disease but the screening test as proposed in the ESC Prevention guideline has not yet been validated or tested
Although the detrimental effects of psychological risk factors on cardiovascular prognosis are known the mechanisms through which they exert these effects are yet unclear It is to be expected that not one but multiple biological inflammation endothelial dysfunction and behavioural coping styles poor self-care consultation behaviour pathological processes play a role and that these processes interact with each other In PCI patients the mechanisms linking psychological risk to poor prognosis are still to be investigated Objective 1 To examine the adherence to the prevention and PCI guidelines and the effects thereof on long term prognosis in PCI patients 2 To examine effects of clustering psychological risk factors on several networks of potentially mediating mechanisms and long term outcomes in a large sample of PCI patients 3 To evaluate the effectiveness of the psychosocial screening instrument of the European Society of Cardiology Prevention guideline 2012 Study design Prospective observational cohort study Study population All patients aged 18 admitted to the TweeSteden hospital for percutaneous coronary intervention are eligible Main study parametersendpoints Predictors Psychological risk factors depression anxiety Type D personality mindfulness positive mood Adherence Outcome variables PCI complications hospitalizations events Nature and extent of the burden and risks associated with participation benefit and group relatedness The risk associated with the current study is very low For this mechanistic observational study investigators will ask patients to fill out two extensive 20 pages and then several smaller 12-15 pages psychological surveys including among others questions on personality positive and negative mood mindfulness work stress and satisfaction with life Preferably questionnaires will be administered digitally by email link There are no direct benefits of participation other than providing data to create knowledge to improve future treatment
Moreover psychological risk factors are important in determining prognosis after PCI and undergoing PCI may increase the risk of low mood To date studies have examined single psychological risk factors without taking into account their relatedness Moreover guidelines are advocating psychosocial screening in early cardiovascular disease but the screening test as proposed in the ESC Prevention guideline has not yet been validated or tested
Although the detrimental effects of psychological risk factors on cardiovascular prognosis are known the mechanisms through which they exert these effects are yet unclear It is to be expected that not one but multiple biological inflammation endothelial dysfunction and behavioural coping styles poor self-care consultation behaviour pathological processes play a role and that these processes interact with each other In PCI patients the mechanisms linking psychological risk to poor prognosis are still to be investigated Objective 1 To examine the adherence to the prevention and PCI guidelines and the effects thereof on long term prognosis in PCI patients 2 To examine effects of clustering psychological risk factors on several networks of potentially mediating mechanisms and long term outcomes in a large sample of PCI patients 3 To evaluate the effectiveness of the psychosocial screening instrument of the European Society of Cardiology Prevention guideline 2012 Study design Prospective observational cohort study Study population All patients aged 18 admitted to the TweeSteden hospital for percutaneous coronary intervention are eligible Main study parametersendpoints Predictors Psychological risk factors depression anxiety Type D personality mindfulness positive mood Adherence Outcome variables PCI complications hospitalizations events Nature and extent of the burden and risks associated with participation benefit and group relatedness The risk associated with the current study is very low For this mechanistic observational study investigators will ask patients to fill out two extensive 20 pages and then several smaller 12-15 pages psychological surveys including among others questions on personality positive and negative mood mindfulness work stress and satisfaction with life Preferably questionnaires will be administered digitally by email link There are no direct benefits of participation other than providing data to create knowledge to improve future treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL4625902813 | OTHER | CCMO | None |