Myocardial InfarctionCP4ACSNCT02961777
Study to Evaluate the Care Process and the Quality of STEMI Care
An observational study of Myocardial Infarction and Acute Coronary Syndrome, run by European Pathway Association.
Trial summary
Cardiovascular diseases, and more precisely patients with ST - elevated myocardial infarction are globally responsible for a large number of hospitalizations and deaths. Monitoring the quality of care for these patients is very relevant topic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute Coronary Syndrome
- What is being tested?
- implementation of care pathway
- How many people
- 640 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2018
- How long will I take part?
- 1 Month
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted with STEMI within 24 hours after symptom onset and eligble for reperfusion according to ESC STEMI guidelines
Who may be able to join
- patients admitted with STEMI within 24 hours after symptom onset and
- eligible for reperfusion according to ESC STEMI guidelines
Who cannot join
- -
About this study
Official title: Study to Evaluate the Care Process and the Quality of Care for Adult Patients With ST Elevated Myocardial Infarction
Cardiovascular diseases, and more precisely patients with ST - elevated myocardial infarction are globally responsible for a large number of hospitalizations and deaths. Monitoring the quality of care for these patients is very relevant topic. Investigators developed indicators from the scientific literature on the quality of care for patients with STEMI at both the patient level and hospital level. The indicators were subsequently validated by a RAND modified Delphi - study of multidisciplinary experts in the care of patients with STEMI.
In this study, the following objectives are set:
Read more
- ) Study of the quality of care for patients with STEMI in 16 Flemish hospitals with cardiology department by retrospective and prospective audit of 20 patient records per participating hospital .
- ) Study of the interdisciplinary relationships and communication within teams involved in the care of patients with STEMI in the participating hospitals 3) Study of perceived organization of care for patients with STEMI in the participating hospitals
In accordance with the objectives of the research, the study consists of three phases:
- ) A retrospective observational audit of 20 patient records of patients with STEMI each participating hospital.
- ) A prospective observational audit of 20 patient records of patients with STEMI each participating hospital.
- ) A survey using validated instruments of interdisciplinary relationships and communication on the one hand and on the other by the teams involved in the care of patients with STEMI perceived organization of care .
Data collection is performed by local researchers and remains their property. The data is coded and kept confidential. Only the local researcher has access to the encryption key. The data are protected by the Belgian law on privacy and medical confidentiality, only to be used in the context of this study. The results are published anonymously.
- Conditions
- Myocardial Infarction, Acute Coronary Syndrome
- Being tested
- implementation of care pathway
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation of care pathwayOther
implementation of a care pathway
| Study group | Role | What they receive |
|---|---|---|
| Time 1 | retrospective evaluation of patient record. no intervention | |
| Time 2 | retrospective evaluation of patient record. no intervention Receives: Other: implementation of care pathway | |
| Time 3 | retrospective evaluation of patient record. no intervention Receives: Other: implementation of care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance on quality indicators at patient level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium (NCT02030210)
This study evaluates quality indicators at patient level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium. The study is limited to the period in which the patients are hospitalized; No data is gathered before or after hospitalization.
Measured: through study completion, an average of 1 year
performance on quality indicators at hospital level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium (NCT02030210)
This study evaluates quality indicators at hospital level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium. The study is limited to the period in which the patients are hospitalized. No data is gathered before or after hospitalization.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Cross-sectional
- Enrolment
- 640 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- European Pathway Association
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Dr. Kris Vanhaecht, European Pathway Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961777
- Sponsor's protocol ID
- CP4ACS\2013\2
- Acronym
- CP4ACS
- Status last verified
- Jul 2018
- First submitted
- 2 Nov 2016
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Care Process and the Quality of Care for Adult Patients With ST Elevated Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02961777
- Acronym / sponsor ID
- CP4ACS / CP4ACS\2013\2
- Conditions
- Myocardial Infarction, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- European Pathway AssociationUniversity, hospital or other
- Collaborators
- KU Leuven, Universitaire Ziekenhuizen KU Leuven
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 11 Nov 2016 (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.
Cardiovascular diseases, and more precisely patients with ST - elevated myocardial infarction are globally responsible for a large number of hospitalizations and deaths. Monitoring the quality of care for these patients is very relevant topic. Investigators developed indicators from the scientific literature on the quality of care for patients with STEMI at both the patient level and hospital level. The indicators were subsequently validated by a RAND modified Delphi - study of multidisciplinary experts in the care of patients with STEMI.
In this study, the following objectives are set:
- ) Study of the quality of care for patients with STEMI in 16 Flemish hospitals with cardiology department by retrospective and prospective audit of 20 patient records per participating hospital .
- ) Study of the interdisciplinary relationships and communication within teams involved in the care of patients with STEMI in the participating hospitals 3) Study of perceived organization of care for patients with STEMI in the participating hospitals
In accordance with the objectives of the research, the study consists of three phases:
- ) A retrospective observational audit of 20 patient records of patients with STEMI each participating hospital.
- ) A prospective observational audit of 20 patient records of patients with STEMI each participating hospital.
- ) A survey using validated instruments of interdisciplinary relationships and communication on the one hand and on the other by the teams involved in the care of patients with STEMI perceived organization of care .
Data collection is performed by local researchers and remains their property. The data is coded and kept confidential. Only the local researcher has access to the encryption key. The data are protected by the Belgian law on privacy and medical confidentiality, only to be used in the context of this study. The results are published anonymously.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Time 1 | – | –retrospective evaluation of patient record. no intervention |
| Time 2 | – | Other: implementation of care pathwayretrospective evaluation of patient record. no intervention |
| Time 3 | – | Other: implementation of care pathwayretrospective evaluation of patient record. no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted with STEMI within 24 hours after symptom onset and eligble for reperfusion according to ESC STEMI guidelines
Key inclusion criteria (2 listed)
- patients admitted with STEMI within 24 hours after symptom onset and
- eligible for reperfusion according to ESC STEMI guidelines
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implementation of care pathwayimplementation of a care pathway | Other | Time 2, Time 3 |
Primary outcome
performance on quality indicators at patient level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium (NCT02030210)
Time frame: through study completion, an average of 1 year
This study evaluates quality indicators at patient level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium. The study is limited to the period in which the patients are hospitalized; No data is gathered before or after hospitalization.
performance on quality indicators at hospital level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium (NCT02030210)
Time frame: through study completion, an average of 1 year
This study evaluates quality indicators at hospital level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium. The study is limited to the period in which the patients are hospitalized. No data is gathered before or after 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 24 Jul 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Acute Coronary Syndrome, run by European Pathway Association.
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 2 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 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
performance on quality indicators at patient level as defined by the CP4ACS Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium (NCT02030210) (time frame: through study completion, an average of 1 year). The study lists 2 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 24 Jul 2018.