Acute Coronary SyndromeNCT02360189
Mechanisms of Social Inequalities in Post-hospitalization Rehabilitation in Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by Nordsjaellands Hospital at 2 sites in Denmark.
Trial summary
Aim: To identify psychological and socioeconomic predictors of cardiac-rehabilitation (CR) attendance and uncover mechanisms of CR non-attendance. Design: Quantitative, observational, prospective study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 310 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2015to Mar 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized with acute coronary syndrome (ACS) to Nordsjællands Hospital (ICD10: DI210-DI219, DI200, DI200B, DI200C, DI23, DI24) will be invited to participate in the survey as an ongoing process during the inclusion period (N=267).
Who may be able to join
- Patients hospitalized with acute coronary syndrome (ACS) to Nordsjællands Hospital (ICD10: DI210-DI219, DI200, DI200B, DI200C, DI23, DI24) will be invited to participate in the survey as an ongoing process during the inclusion period (N=267).
Who cannot join
- Patients who are not able to submit written consent are excluded. Thus, patients with severe cognitive dysfunction or poor language skills are excluded.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Nordsjællands Hospital, Frederikssund.
Frederikssund, 3600
Nordsjællands Hospital, Hillerød
Hillerød, 3400
About this study
Aim: To identify psychological and socioeconomic predictors of cardiac-rehabilitation (CR) attendance and uncover mechanisms of CR non-attendance.
Design: Quantitative, observational, prospective study. Hypothesis a: Educational-level, comorbidity, anxiety, depression, self-efficacy, cohabitation and distance from residence are predictors of CR attendance.
Hypothesis b: The expected social gradient in CR attendance is explained partly by differential exposure of comorbidity, anxiety, depression, self-efficacy, cohabitation and distance to the rehabilitation clinic.
Read the detailed description
Design: Quantitative, observational, prospective study. Self-administrated questionnaires, medical journals and telephone interviews will be used for data collecting.
- 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.
Cardiac-rehabilitation attendance (yes/no)
Measured: 3 months post hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2016
- Study completionMar 2018
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
- Other
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Pedersen, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360189
- Sponsor's protocol ID
- ACS-12345
- Status last verified
- Mar 2018
- First submitted
- 26 Nov 2014
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Social Inequalities in Post-hospitalization Rehabilitation in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02360189
- Acronym / sponsor ID
- ACS-12345
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 10 Feb 2015 (estimated)
- 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.
Aim: To identify psychological and socioeconomic predictors of cardiac-rehabilitation (CR) attendance and uncover mechanisms of CR non-attendance.
Design: Quantitative, observational, prospective study. Hypothesis a: Educational-level, comorbidity, anxiety, depression, self-efficacy, cohabitation and distance from residence are predictors of CR attendance.
Hypothesis b: The expected social gradient in CR attendance is explained partly by differential exposure of comorbidity, anxiety, depression, self-efficacy, cohabitation and distance to the rehabilitation clinic.
Detailed description
Design: Quantitative, observational, prospective study. Self-administrated questionnaires, medical journals and telephone interviews will be used for data collecting.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized with acute coronary syndrome (ACS) to Nordsjællands Hospital (ICD10: DI210-DI219, DI200, DI200B, DI200C, DI23, DI24) will be invited to participate in the survey as an ongoing process during the inclusion period (N=267).
Key inclusion criteria (1 listed)
- Patients hospitalized with acute coronary syndrome (ACS) to Nordsjællands Hospital (ICD10: DI210-DI219, DI200, DI200B, DI200C, DI23, DI24) will be invited to participate in the survey as an ongoing process during the inclusion period (N=267).
Key exclusion criteria (1 listed)
- Patients who are not able to submit written consent are excluded. Thus, patients with severe cognitive dysfunction or poor language skills are excluded.
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
Cardiac-rehabilitation attendance (yes/no)
Time frame: 3 months post hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Nordsjaellands Hospital at 2 sites in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac-rehabilitation attendance (yes/no) (time frame: 3 months post hospitalization). 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 29 Mar 2018.