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Ischemic Cardiovascular DiseasePICTURENCT05696873

CoPing strategIes-psyChological flexibiliTy in Patients Hospitalized for Ischemic cardiovascUlaR disEase (PICTURE)

An observational study of Ischemic Cardiovascular Disease, run by Cardiocentro Ticino at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this trial is to investigate the coping strategies/physiological flexibility construct in patients hospitalized for ischemic cardiovascular disease and the possible association with recurrence of clinical events (any hospitalization and type thereof, myocardial infarction, stroke and death) during the… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Ischemic Cardiovascular Disease
How many people
80 participants
Where
1 siteSwitzerland
Study dates
9 Feb 2023to 31 Dec 2025
How long will I take part?
2 Years
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with age ≥ 18 years old and admission to the hospital for ischemic cardiovascular disease.

Who may be able to join

  • Age ≥ 18 years old
  • Able to provide informed consent
  • Able to speak and read in the local language spoken in hospital
  • Admission to the hospital for ischemic cardiovascular disease

Who cannot join

  • Cannot provide written informed consent
  • Under judicial protection, tutorship or curatorship
  • Unable to understand and follow study-related instructions or unable to comply with study protocol
  • Cognitive impairment
  • Severe psychiatric disorders according to DSM-5-TR criteria diagnosed in the last 6 months

Trial locations and contacts

1 site in 1 country.

Marco Valgimigli, M.D., Ph.D contact

+410918115111

marco.valgimigli@eoc.ch

enrico frigoli, M.D. contact

enricofrigoli@gmail.com

Switzerland1 site, 1 recruiting

  • Enrico Frigoli

    Lugano, 6900

    Enrico Frigoli, MD, enrico.frigoli@eoc.ch

    Recruiting

Other trials in Switzerland

About this study

The aim of this trial is to investigate the coping strategies/physiological flexibility construct in patients hospitalized for ischemic cardiovascular disease and the possible association with recurrence of clinical events (any hospitalization and type thereof, myocardial infarction, stroke and death) during the follow up, the patient's decision to participate to clinical trials approved in the center and the adherence to cardiovascular medications.

Keywords
ischemic cardiovascular disease, mental stress, coping strategies, patient's decision to partecipate to clinical trial, adherence to the medications, psychological flexibility, acceptance and commitment therapy, hexaflex, Brief Cope test, MPFI test, CFQ test, MAAS-8 test, CVD-AAQ test
Medical subject headings
Stress, Psychological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. coping strategies and the recurrence of any hospitalization and type thereof, myocardial infarction, stroke and death during the follow up period (2 years±14 days from index hospitalization)

    coping strategies (evaluated using Brief COPE test) and the recurrence of clinical events (any hospitalization and type thereof, myocardial infarction, stroke and death) during the follow up period (2 years±14 days from index hospitalization)

    Measured: 2 years (±14 days) from index hospitalization

  2. psychological flexibility and the recurrence any hospitalization and type thereof, myocardial infarction, stroke and death during the follow up period (2 years±14 days from index hospitalization)

    psychological flexibility construct (evaluated using MPFI test - Multidimensional Psychological Flexibility Inventory test and CFQ test - Cognitive Fusion Questionnaire) and the recurrence of clinical events (any hospitalization and type thereof, myocardial infarction, stroke and death) during the follow up period (2 years±14 days from index hospitalization)

    Measured: 2 years (±14 days) from index hospitalization

  3. coping strategies and the patient's decision to participate to the clinical trials approved in the centres

    coping strategies (evaluated using Brief COPE test) and the patient's decision to participate to the clinical trials approved in the centres

    Measured: at discharge of index hospitalization (up to 4 weeks)

  4. psychological flexibility and the patient's decision to participate to the clinical trials approved in the centres

    psychological flexibility construct (evaluated using MPFI test - Multidimensional Psychological Flexibility Inventory test and CFQ test - Cognitive Fusion Questionnaire) and the patient's decision to participate to the clinical trials approved in the centres

    Measured: at discharge of index hospitalization (up to 4 weeks)

  5. coping strategies and the adherence to cardiovascular medications

    coping strategies (evaluated using Brief COPE test) and the adherence to cardiovascular medications

    Measured: 2 years (±14 days) from index hospitalization

  6. psychological flexibility and the adherence to cardiovascular medications

    psychological flexibility construct (evaluated using MPFI test and - Multidimensional Psychological Flexibility Inventory test and CFQ test - Cognitive Fusion Questionnaire) and the adherence to cardiovascular medications

    Measured: 2 years (±14 days) from index hospitalization

Secondary outcomes (10)

  1. each coping strategy and the recurrence of any hospitalization and type thereof, myocardial infarction, stroke and death

    each coping strategy (evaluated using Brief COPE test) and the recurrence of clinical events type (any hospitalization and type thereof, myocardial infarction, stroke and death)

    Measured: 2 years (±14 days) from index hospitalization

  2. each component of psychological flexibility model and the recurrence of any hospitalization and type thereof, myocardial infarction, stroke and death

    each component of psychological flexibility model (evaluated using MPFI test - Multidimensional Psychological Flexibility Inventory test and CFQ test - Cognitive Fusion Questionnaire) and the recurrence of clinical events type (any hospitalization and type thereof, myocardial infarction, stroke and death)

    Measured: 2 years (±14 days) from index hospitalization

  3. each coping strategy (evaluated using Brief COPE test) and the participation to each proposed clinical trial, with a particular focus on the SOS-AMI trial

    each coping strategy (evaluated using Brief COPE test) and the participation to each proposed clinical trial, with a particular focus on the SOS-AMI trial, since it requires copying with the patient decision to self-administer treatment unlike other studies in which treatment is physician-directed

    Measured: at discharge of index hospitalization (up to 4 weeks)

  4. each component of psychological flexibility and the participation to each proposed clinical trial, with a particular focus on the SOS-AMI trial

    each component of psychological flexibility construct (evaluated using MPFI test and - Multidimensional Psychological Flexibility Inventory test and CFQ test - Cognitive Fusion Questionnaire) and the participation to each proposed clinical trial, with a particular focus on the SOS-AMI trial, since it requires copying with the patient decision to self-administer treatment unlike other studies in which treatment is physician-directed

    Measured: at discharge of index hospitalization (up to 4 weeks)

  5. cognitive fusion and recurrence of cardiovascular events

    cognitive fusion (evaluated using CFQ test - Cognitive Fusion Questionnaire) and recurrence of cardiovascular events

    Measured: at 2 years (±14 days) from index hospitalization

  6. cognitive fusion and participation to the trials

    cognitive fusion (evaluated using CFQ test - Cognitive Fusion Questionnaire) and participation to the trials

    Measured: at discharge of index hospitalization (up to 4 weeks)

  7. cognitive fusion and adherence to cardiovascular medications

    cognitive fusion (evaluated using CFQ test - Cognitive Fusion Questionnaire) and adherence to cardiovascular medications

    Measured: at 2 years (±14 days) from index hospitalization

  8. psychological flexibility evaluated with CVD-AAQ test and cardiovascular events

    psychological flexibility evaluated with CVD-AAQ test (Cardiovascular Disease Acceptance and Action Questionnaire) and cardiovascular events

    Measured: at 2 years (±14 days) from index hospitalization

  9. psychological flexibility evaluated with CVD-AAQ test and participation to the trials

    psychological flexibility evaluated with CVD-AAQ test (Cardiovascular Disease Acceptance and Action Questionnaire) and participation to the trials

    Measured: at discharge of index hospitalization (up to 4 weeks)

  10. psychological flexibility evaluated with CVD-AAQ test and adherence to cardiovascular medications

    psychological flexibility evaluated with CVD-AAQ test (Cardiovascular Disease Acceptance and Action Questionnaire) and adherence to cardiovascular medications

    Measured: at 2 years (±14 days) from index hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study start9 Feb 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05696873
Sponsor's protocol ID
02_PICTURE
Acronym
PICTURE
Status last verified
May 2024
First submitted
21 Dec 2022
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Cardiovascular Disease, run by Cardiocentro Ticino at 1 site in Switzerland.

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 4 inclusion and 5 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 May 2024. 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 Switzerland. 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 Marco Valgimigli, M.D., Ph.D (+410918115111, marco.valgimigli@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

coping strategies and the recurrence of any hospitalization and type thereof, myocardial infarction, stroke and death during the follow up period (2 years±14 days from index hospitalization) (time frame: 2 years (±14 days) from index hospitalization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05696873.

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 May 2024.

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