A NIS Registry of the Prospective Structured Care In Acute Coronary Syndrome (ProAcor)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01490645
First received: December 9, 2011
Last updated: September 4, 2014
Last verified: September 2014
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Purpose
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.
| Condition |
|---|
|
Acute Coronary Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry |
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]after collecting all Case Record Form
Secondary Outcome Measures:
- Description of reasons of premature withdrawal from the program. [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]after collecting all Case Record Form
- Description of changes in quality of life (QoL) during the period of 12 months. [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]after collecting all Case Record Form
- 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 ] [ Designated as safety issue: No ]after collecting all Case Record Form
- Description of patients's needs in long term care of ACS. [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]after collecting all Case Record Form
- 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 ] [ Designated as safety issue: No ]after collecting all Case Record Form
- 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 ] [ Designated as safety issue: No ]after collecting all Case Record Form
- Frequency of changes in ambulant treatment according to the acceptance of the program. [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]after collecting all Case Record Form
- Frequency of newly occurred symptomatic acute cardiac events according to the acceptance of the program. [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]after collecting all Case Record Form
- Frequency of resource use according to the acceptance of the program. [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]after collecting all Case Record Form
| Enrollment: | 1006 |
| Study Start Date: | December 2011 |
| Study Completion Date: | August 2014 |
| Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| one group (all patients) |
Detailed Description:
ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Regional centres / hospitals with a significant number of ACS patients
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490645
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490645
Locations
| Germany | |
| Research Site | |
| Arnstadt, Germany | |
| Research Site | |
| Augsburg, Germany | |
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| Bad Soden, Germany | |
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| Berlin-Helersdorf, Germany | |
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| Berlin-Humbold, Germany | |
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| Berlin-Lichtenberg, Germany | |
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| Berlin-Neukoelln, Germany | |
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| Berlin-Pankow, Germany | |
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| Berlin-Spandau, Germany | |
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| Berlin, Germany | |
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| Bonn, Germany | |
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| Buchholz, Germany | |
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| Chemnitz, Germany | |
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| Coburg, Germany | |
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| Coswig, Germany | |
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| Cottbus, Germany | |
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| Dessau-Rosslau, Germany | |
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| Dinslaken, Germany | |
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| Duesseldorf, Germany | |
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| Flensburg, Germany | |
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| Frankfurt, Germany | |
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| Goettingen, Germany | |
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| Hamburg, Germany | |
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| Hilden, Germany | |
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| Hochberg, Germany | |
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| Hoexter, Germany | |
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| Karlstadt, Germany | |
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| Kassel, Germany | |
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| Kiel, Germany | |
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| Koeln, Germany | |
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| Lippstadt, Germany | |
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| Loerrach, Germany | |
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| Luenen, Germany | |
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| Magdeburg, Germany | |
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| Merseburg, Germany | |
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| Nordhausen, Germany | |
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| Querfurt, Germany | |
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| Regensburg, Germany | |
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| Stralsund, Germany | |
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| Templin, Germany | |
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| Ulm Donau, Germany | |
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| Ulm, Germany | |
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| Wesel, Germany | |
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| Wilster, Germany | |
| Research Site | |
| Wuerzburg, Germany | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Helmut Brasch, Prof. Dr. | AstraZeneca Germany |
| Principal Investigator: | Franz Goss, Dr. med. | 80331 Munich, Germany |
More Information
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01490645 History of Changes |
| Other Study ID Numbers: | NIS-CDE-XXX-2011/1 |
| Study First Received: | December 9, 2011 |
| Last Updated: | September 4, 2014 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by AstraZeneca:
|
ACS patients participating in a SCP QoL after ACS ASC Patients's needs |
Additional relevant MeSH terms:
|
Syndrome Acute Coronary Syndrome Disease Pathologic Processes |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on September 23, 2016