Acute Coronary SyndromeNCT05341440
Deciphering the Salutogenic Effects of Close Relationships: Psycho-physiological Coregulation Processes and Their Outcomes in Couples Coping With Cardiovascular Disease
An observational study of Acute Coronary Syndrome, run by Bar-Ilan University, Israel at 1 site in Israel.
Trial summary
The established attachment theory elucidates how early human bonds bring about functional neurophysiological alterations influencing the lifelong capacity for self and co- regulation within relationships. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 81 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Mar 2022to 22 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The target population will be male patients with the diagnosis of a first Acute Coronary Syndrome who have been registered in the cardiac prevention and rehabilitation center (CPRC) and are in a committed relationship (i.e., cohabiting for at least one year).
Who may be able to join
- First Acute Coronary Syndrome
- In a committed relationship lasting over a year
- Registration at the Cardiac Prevention and Rehabiliation Center (CPRC)
Who cannot join
- A history of previous cardiac events
- A diagnosis other than Acute Coronary Syndrome, co-morbid conditions (such as cancer),
- Lack of Hebrew as a native language.
- Exclusion criteria for partners will be severe co-morbid conditions with life expectancy of less than 6 months (such as advanced cancer) and lack of Hebrew as a native language.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, Hamercaz
Jenny Gutman, +972547851988, jenny.e.gutman@gmail.com
About this study
The established attachment theory elucidates how early human bonds bring about functional neurophysiological alterations influencing the lifelong capacity for self and co- regulation within relationships. Based on this framework, the study will investigate potential psycho-physiological co-regulation processes in couples coping with cardiovascular disease, which may explain the established link between relationship satisfaction and recovery outcomes. In the proposed prospective, longitudinal study, the investigators will follow 81 volunteer couples in which one member has experienced an Acute Coronary Syndrome and assess their levels of interactive behavioral synchrony and the accompanying physiological synchrony (the mutual coordination of spouses' autonomic nervous systems), and stress buffering (reduced reactivity to stress in the individual) as assessed by Heart Rate Variability, and Galvanic Skin Response. It is hypothesized that higher levels of physiological synchrony and stress buffering will be associated with enhanced behavioral synchrony in the lab as well as patient outcomes three months later, on three dimensions: emotional (anxiety and depression reduction); behavioral (smoking cessation, medication adherence, cardiac rehabilitation participation) and physical (weight reduction, increased fitness).
- Conditions
- Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale
contains 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal'.
Measured: 3 months
The Warwich-Edinburgh Mental Well-being Scale
A scale of 14 positively worded items for assessing a population's mental wellbeing. Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
Measured: 3 months
Smoking cessation
Smoking cessation will be defined as the delta between the number of cigarettes smoked before the cardiac event and the number of cigarettes smoked 3 months after the start of rehabilitation.
Measured: 3 months
The Medication Adherence Report Scale
Patients will be asked to report on their medication adherence, using the Medication Adherence Rating Scale. Responses are summed for a total score ranging between 5 and 25, with higher scores indicating a higher level of adherence.
Measured: 3 months
Cardiac rehabilitation participation
The number of times patients participated in supervised exercise in the Cardiac Rehabilitation Center. Information regarding Rehabilitation participation will be retrieved from patients' computerized entry files.
Measured: 3 months
Weight change
Weight change is defined as the delta between patients' body-mass index (BMI) from the beginning of rehabilitation and 3 months in.
Measured: 3 months
Fitness change
Will be defined as the change in delta between 3 months after the start of rehabilitation ergometry score and the start of rehabilitation ergometry score (in Metabolic Equivalent of Task Score- METs).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start22 Mar 2022
- Primary completion22 Mar 2024 (estimated)
- Study completion22 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noa Vilchinsky, Bar-Ilan University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341440
- Sponsor's protocol ID
- 27122021
- Status last verified
- Feb 2023
- First submitted
- 28 Mar 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Salutogenic Effects of Close Relationships: Psycho-physiological Coregulation Processes and Their Outcomes in Couples Coping With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05341440
- Acronym / sponsor ID
- 27122021
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 22 Mar 2024 (estimated)
- Study completion
- 22 Jun 2024 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The established attachment theory elucidates how early human bonds bring about functional neurophysiological alterations influencing the lifelong capacity for self and co- regulation within relationships. Based on this framework, the study will investigate potential psycho-physiological co-regulation processes in couples coping with cardiovascular disease, which may explain the established link between relationship satisfaction and recovery outcomes. In the proposed prospective, longitudinal study, the investigators will follow 81 volunteer couples in which one member has experienced an Acute Coronary Syndrome and assess their levels of interactive behavioral synchrony and the accompanying physiological synchrony (the mutual coordination of spouses' autonomic nervous systems), and stress buffering (reduced reactivity to stress in the individual) as assessed by Heart Rate Variability, and Galvanic Skin Response. It is hypothesized that higher levels of physiological synchrony and stress buffering will be associated with enhanced behavioral synchrony in the lab as well as patient outcomes three months later, on three dimensions: emotional (anxiety and depression reduction); behavioral (smoking cessation, medication adherence, cardiac rehabilitation participation) and physical (weight reduction, increased fitness).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population will be male patients with the diagnosis of a first Acute Coronary Syndrome who have been registered in the cardiac prevention and rehabilitation center (CPRC) and are in a committed relationship (i.e., cohabiting for at least one year).
Key inclusion criteria (3 listed)
- First Acute Coronary Syndrome
- In a committed relationship lasting over a year
- Registration at the Cardiac Prevention and Rehabiliation Center (CPRC)
Key exclusion criteria (4 listed)
- A history of previous cardiac events
- A diagnosis other than Acute Coronary Syndrome, co-morbid conditions (such as cancer),
- Lack of Hebrew as a native language.
- Exclusion criteria for partners will be severe co-morbid conditions with life expectancy of less than 6 months (such as advanced cancer) and lack of Hebrew as a native language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital Anxiety and Depression Scale
Time frame: 3 months
contains 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal'.
The Warwich-Edinburgh Mental Well-being Scale
Time frame: 3 months
A scale of 14 positively worded items for assessing a population's mental wellbeing. Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
Smoking cessation
Time frame: 3 months
Smoking cessation will be defined as the delta between the number of cigarettes smoked before the cardiac event and the number of cigarettes smoked 3 months after the start of rehabilitation.
The Medication Adherence Report Scale
Time frame: 3 months
Patients will be asked to report on their medication adherence, using the Medication Adherence Rating Scale. Responses are summed for a total score ranging between 5 and 25, with higher scores indicating a higher level of adherence.
Cardiac rehabilitation participation
Time frame: 3 months
The number of times patients participated in supervised exercise in the Cardiac Rehabilitation Center. Information regarding Rehabilitation participation will be retrieved from patients' computerized entry files.
Weight change
Time frame: 3 months
Weight change is defined as the delta between patients' body-mass index (BMI) from the beginning of rehabilitation and 3 months in.
Fitness change
Time frame: 3 months
Will be defined as the change in delta between 3 months after the start of rehabilitation ergometry score and the start of rehabilitation ergometry score (in Metabolic Equivalent of Task Score- METs).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Bar-Ilan University, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenny Gutman (0547851988, jenny.e.gutman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.