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NCT05003791 · ClinicalTrials.gov registry record
Perceived Social Support, Heart Rate Variability, and Hopelessness in Patients With Ischemic Heart Disease
A clinical trial, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- 48
- Enrollment target
NCT05003791: Completed study, sponsored by University of Illinois at Chicago.
NCT05003791 is a clinical trial that has completed, run by University of Illinois at Chicago. The registered enrollment target is 48 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05003791 has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- 48 participants
- Enrollment target
Study Summary
Cardiovascular disease is the leading cause of death worldwide, with ischemic heart disease (IHD) the leading cause of cardiovascular mortality. Persons with IHD suffering from psychological distress, including hopelessness, are more likely to die from IHD. Following a stressful event, the vagus nerve enables activation of either a sympathetic (fight/flight) or parasympathetic (rest/digest) response. Heart rate variability (HRV), the beat-to-beat variability between normal successive heart beats, is a biomarker of both adaptive and maladaptive reactions to stress. Decreased HRV predicts greater risk for morbidity and mortality and is associated with poor mental health outcomes in persons with IHD. As stated by polyvagal theory, HRV may be influenced by social support. Decreased perceived social support (PSS), a social determinant of cardiovascular risk, is predictive of increased morbidity and mortality in persons with IHD. Decreased PSS has been associated with hopelessness in patients with cancer, but this relationship has not been studied in IHD beyond the applicant's small pilot study of patients with hopelessness. Hopelessness, a negative outlook and sense of helplessness about the future, is present in 27-52% of patients with IHD. This is of grave concern, because hopelessness is associated with a 3.4 times increased risk of mortality and nonfatal myocardial infarction in patients with IHD, independent of depression. This research focuses on understanding the biological (HRV) and social (PSS) aspects of hopelessness, with the long-term goal of developing and testing novel interventions to reduce the adverse effects of hopelessness and improve health outcomes in patients with IHD. Participants for this cross-sectional study will be recruited while hospitalized for an IHD event. Participants will include patients who report moderate to severe hopelessness from the sponsor's NIH-funded study (n = 225); additional patients with minimal to no hopelessness will be r
Primary Outcome
The State-Trait Hopelessness Scale (STHS) was used to measure state hopelessness. The STHS uses a Likert-type scale ranging from 1 (strongly disagree) to 4 (strongly agree) and differentiates state and trait hopelessness. For the 10-item state subscale, participants respond to statements based on how they feel "today (right now)." The responses for each subscale are totaled and divided by the number of items in the subscale to provide a final score ranging from one to four, with lower scores ind
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2023-03-24 |
What the finished NCT05003791 record still lists
NCT05003791 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 48 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05003791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05003791 about?
NCT05003791 is a clinical study titled "Perceived Social Support, Heart Rate Variability, and Hopelessness in Patients With Ischemic Heart Disease". Cardiovascular disease is the leading cause of death worldwide, with ischemic heart disease (IHD) the leading cause of cardiovascular mortality. Persons with IHD suffering from psychological distress, including hopelessness, are more likely to die from IHD. Following a stressful event, the vagus ner...
What is the current status of trial NCT05003791?
This trial is currently completed. The enrollment target is 48 participants. The study started on 2021-09-01. Estimated completion is 2023-03-24.
Who is sponsoring clinical trial NCT05003791?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
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