Acute Coronary SyndromeProAcorNCT01490645
A NIS Registry of the Prospective Structured Care In Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 45 sites in Germany.
Trial summary
The purpose of the study is to analyse patient's acceptance and willingness to participate in a Structured Care Program (SCP) over 12 months following hospital discharge after Acute Coronary Syndrome (ACS) index event. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 1,006 participants
- Where
- 45 sitesGermany
- Study dates
- Dec 2011to Aug 2014
- 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: Regional centres / hospitals with a significant number of ACS patients
Who may be able to join
- Patients hospitalized because of ACS (ST segment elevation myocardial infarction (STEMI)), non-ST elevation myocardial infarction (NSTEMI) Unstable Angina (UA)) and planned to be discharged alive soon.
Who cannot join
- Myocardial infarction (UA, STEMI and NSTEMI) precipitated by or as a complication of surgery, trauma, or Gastrointestinal Bleeding or post- percutaneous coronary intervention (PCI).
- Myocardial infarction (UA, STEMI and NSTEMI) occurring in patients already hospitalized for other reasons.
- Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, known diagnosed psychiatric illness
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
Germany45 sites
Research Site
Arnstadt
Research Site
Augsburg
Research Site
Bad Soden
Research Site
Berlin
Research Site
Berlin-Helersdorf
Research Site
Berlin-Humbold
Research Site
Berlin-Pankow
Research Site
Berlin-Spandau
Research Site
Bonn
Research Site
Buchholz
Research Site
Chemnitz
Research Site
Coburg
Research Site
Cologne
Research Site
Coswig
Research Site
Cottbus
Research Site
Dessau
Research Site
Dinslaken
Research Site
Düsseldorf
Research Site
Flensburg
Research Site
Frankfurt
Research Site
Göttingen
Research Site
Hamburg
Research Site
Hilden
Research Site
Höchberg
Research Site
Höxter
Research Site
Karlstadt am Main
Research Site
Kassel
Research Site
Kiel
Research Site
Lichtenberg
Research Site
Lippstadt
Research Site
Loerrach
Research Site
Lünen
Research Site
Magdeburg
Research Site
Merseburg
Research Site
Neukölln
Research Site
Nordhausen
Research Site
Querfurt
Research Site
Regensburg
Research Site
Stralsund
Research Site
Templin
Research Site
Ulm
Research Site
Ulm Donau
Research Site
Wesel
Research Site
Wilster
Research Site
Würzburg
About this study
Official title: ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry
The purpose of the study is to analyse patient's acceptance and willingness to participate in a Structured Care Program (SCP) over 12 months following hospital discharge after Acute Coronary Syndrome (ACS) index event.
Read the detailed description
ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS patients participating in a SCP, QoL after ACS, ASC Patients's needs
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| one group (all patients) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients who can be guided through the structured outpatient care program offered within this project by assessing the percentage of patients with diagnosis of Acute Coronary Syndrome (ACS) following the care program.
after collecting all Case Record Form
Measured: up to 24 months
Secondary outcomes (9)
Description of reasons of premature withdrawal from the program.
after collecting all Case Record Form
Measured: up to 12 months
Description of changes in quality of life (QoL) during the period of 12 months.
after collecting all Case Record Form
Measured: up to 12 months
Description of acceptance of the program between subgroups (e.g. gender, risk scores, types of ACS, multimorbidity, medical treatment, therapy).
after collecting all Case Record Form
Measured: up to 12 months
Description of patients's needs in long term care of ACS.
after collecting all Case Record Form
Measured: up to 12 months
Description of adherence to guideline conform treatment and patients' compliance with the lifestyle changes recommended by the physician (e.g. body weight, blood pressure, Low Density Lipoprotein (LDL)).
after collecting all Case Record Form
Measured: up to 12 months
Description of newly occurred cardiac symptoms (e.g. troponin, LVH), as determined by routine examinations by the cardiologists, which cause a declining state of health.
after collecting all Case Record Form
Measured: up to 12 months
Frequency of changes in ambulant treatment according to the acceptance of the program.
after collecting all Case Record Form
Measured: up to 12 months
Frequency of newly occurred symptomatic acute cardiac events according to the acceptance of the program.
after collecting all Case Record Form
Measured: up to 12 months
Frequency of resource use according to the acceptance of the program.
after collecting all Case Record Form
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2014
- Study completionAug 2014
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 1,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helmut Brasch, Prof. Dr., Study director, AstraZeneca GermanyFranz Goss, Dr. med., Principal investigator, 80331 Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490645
- Sponsor's protocol ID
- NIS-CDE-XXX-2011/1
- Other IDs
- NIS-CDE-XXX-2011/1
- Acronym
- ProAcor
- Status last verified
- Sep 2014
- First submitted
- 9 Dec 2011
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry
- ClinicalTrials.gov ID
- NCT01490645
- Acronym / sponsor ID
- ProAcor / NIS-CDE-XXX-2011/1
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS patients participating in a SCP, QoL after ACS, ASC Patients's needs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,006 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Dec 2011 (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 purpose of the study is to analyse patient's acceptance and willingness to participate in a Structured Care Program (SCP) over 12 months following hospital discharge after Acute Coronary Syndrome (ACS) index event.
Detailed description
ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group (all patients) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Regional centres / hospitals with a significant number of ACS patients
Key inclusion criteria (1 listed)
- Patients hospitalized because of ACS (ST segment elevation myocardial infarction (STEMI)), non-ST elevation myocardial infarction (NSTEMI) Unstable Angina (UA)) and planned to be discharged alive soon.
Key exclusion criteria (3 listed)
- Myocardial infarction (UA, STEMI and NSTEMI) precipitated by or as a complication of surgery, trauma, or Gastrointestinal Bleeding or post- percutaneous coronary intervention (PCI).
- Myocardial infarction (UA, STEMI and NSTEMI) occurring in patients already hospitalized for other reasons.
- Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, known diagnosed psychiatric illness
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
The number of patients who can be guided through the structured outpatient care program offered within this project by assessing the percentage of patients with diagnosis of Acute Coronary Syndrome (ACS) following the care program.
Time frame: up to 24 months
after collecting all Case Record Form
9 secondary outcomes
Description of reasons of premature withdrawal from the program.
Time frame: up to 12 months
Description of changes in quality of life (QoL) during the period of 12 months.
Time frame: up to 12 months
Description of acceptance of the program between subgroups (e.g. gender, risk scores, types of ACS, multimorbidity, medical treatment, therapy).
Time frame: up to 12 months
Description of patients's needs in long term care of ACS.
Time frame: up to 12 months
Description of adherence to guideline conform treatment and patients' compliance with the lifestyle changes recommended by the physician (e.g. body weight, blood pressure, Low Density Lipoprotein (LDL)).
Time frame: up to 12 months
Description of newly occurred cardiac symptoms (e.g. troponin, LVH), as determined by routine examinations by the cardiologists, which cause a declining state of health.
Time frame: up to 12 months
Frequency of changes in ambulant treatment according to the acceptance of the program.
Time frame: up to 12 months
Frequency of newly occurred symptomatic acute cardiac events according to the acceptance of the program.
Time frame: up to 12 months
Frequency of resource use according to the acceptance of the program.
Time frame: up to 12 months
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 5 Sep 2014.
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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.
Helmut Brasch, Prof. Dr. study director
AstraZeneca Germany
Franz Goss, Dr. med. principal investigator
80331 Munich, Germany
45 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 AstraZeneca at 45 sites 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 3 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 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites 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?
The number of patients who can be guided through the structured outpatient care program offered within this project by assessing the percentage of patients with diagnosis of Acute Coronary Syndrome (ACS) following the care program. (time frame: up to 24 months). 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 5 Sep 2014.