Chest PainNCT01197716
German Chest Pain Unit (CPU)-Register
An observational study of Chest Pain, run by Stiftung Institut fuer Herzinfarktforschung at 1 site in Germany.
Trial summary
The Chest Pain Unit (CPU) register is a nationwide scientific investigation, in which data concerning the hospital-stay within the Chest Pain Unit are documented. Furthermore, a Follow-up via telephone is conducted after 3 months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chest Pain
- How many people
- 34,470 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2008to Dec 2015
- 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 admitted to a chest pain unit in a primary care clinic
Who may be able to join
- All patients that are admitted to a Chest Pain Unit are included in this register.
Who cannot join
- Missing informed consent (informed consent can NOT be given in the acute phase of the disease, if consciousness is limited at that time; instead the patient will be asked for his consent at a later point of time, when he is fully conscious).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deutsches CPU-Register. Unterstützt Durch Die Deutsche Gesellschaft für Kardiologie.
The Chest Pain Unit (CPU) register is a nationwide scientific investigation, in which data concerning the hospital-stay within the Chest Pain Unit are documented. Furthermore, a Follow-up via telephone is conducted after 3 months.
Read the detailed description
The aim of a Chest Pain Unit (CPU) is to clarify unclear chest pain quickly and specifically. Present data from Germany, the USA and England prove that the organisation models of a CPU lead beside a drastic reduction of mortality also to a cost reduction as well as a shortening of the average inpatient hospital stays.
Therefore it seems reasonable to assign a minimum standard to CPUs. Although there are internationally already standards for CPUs up to complete certification programmes, it is an explicit wish of the German society for cardiology (DGK) to create an own standard which considers on the national circumstances.
The aim of the CPU register is the internal and external validation of the care quality of CPU including Benchmark reports and risk-adjusted comparisons.
- Conditions
- Chest Pain
- Keywords
- Chest Pain Unit, Myocardial infarction, Register, Admission to a Chest Pain Unit for any reason
- Medical subject headings
- Chest Pain, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal and external validation of the medical care quality in the field of Chest Pain Units
including benchmark reports and risk adjusted comparisons.
Measured: hospital stay
Secondary outcomes (2)
Documentation of CPU complications
including mortality, serious but non-fatal complications (e.g. stroke, heavy and moderate bleedings) as well as documentation of the medication at hospital discharge
Measured: up to 30 hours on average
Documentation of long-term mortality and serious but non-fatal complications
as well as additional hospital admissions and medication
Measured: 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startDec 2008
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34,470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harald Darius, MD, Study chair, Vivantes Clinic Neukölln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197716
- Sponsor's protocol ID
- German CPU-Register
- Status last verified
- Jun 2016
- First submitted
- 7 Sep 2010
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deutsches CPU-Register. Unterstützt Durch Die Deutsche Gesellschaft für Kardiologie.
- ClinicalTrials.gov ID
- NCT01197716
- Acronym / sponsor ID
- German CPU-Register
- Conditions
- Chest Pain
- Keywords
- Chest Pain Unit, Myocardial infarction, Register, Admission to a Chest Pain Unit for any reason
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34,470 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Sep 2010 (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.
The Chest Pain Unit (CPU) register is a nationwide scientific investigation, in which data concerning the hospital-stay within the Chest Pain Unit are documented. Furthermore, a Follow-up via telephone is conducted after 3 months.
Detailed description
The aim of a Chest Pain Unit (CPU) is to clarify unclear chest pain quickly and specifically. Present data from Germany, the USA and England prove that the organisation models of a CPU lead beside a drastic reduction of mortality also to a cost reduction as well as a shortening of the average inpatient hospital stays.
Therefore it seems reasonable to assign a minimum standard to CPUs. Although there are internationally already standards for CPUs up to complete certification programmes, it is an explicit wish of the German society for cardiology (DGK) to create an own standard which considers on the national circumstances.
The aim of the CPU register is the internal and external validation of the care quality of CPU including Benchmark reports and risk-adjusted comparisons.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to a chest pain unit in a primary care clinic
Key inclusion criteria (1 listed)
- All patients that are admitted to a Chest Pain Unit are included in this register.
Key exclusion criteria (1 listed)
- Missing informed consent (informed consent can NOT be given in the acute phase of the disease, if consciousness is limited at that time; instead the patient will be asked for his consent at a later point of time, when he is fully conscious).
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
Internal and external validation of the medical care quality in the field of Chest Pain Units
Time frame: hospital stay
including benchmark reports and risk adjusted comparisons.
2 secondary outcomes
Documentation of CPU complications
Time frame: up to 30 hours on average
Documentation of long-term mortality and serious but non-fatal complications
Time frame: 3 months after discharge
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 Jun 2016.
- 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.
Harald Darius, MD study chair
Vivantes Clinic Neukölln
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 Chest Pain, run by Stiftung Institut fuer Herzinfarktforschung at 1 site in Germany.
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 24 Jun 2016. 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 Germany. 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?
Internal and external validation of the medical care quality in the field of Chest Pain Units (time frame: hospital stay). 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 Jun 2016.