A NIS Registry of the Prospective Structured Care In Acute Coronary Syndrome (ProAcor)
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| ClinicalTrials.gov Identifier: NCT01490645 |
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Recruitment Status :
Completed
First Posted : December 13, 2011
Last Update Posted : September 5, 2014
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief 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.
| Condition or disease |
|---|
| Acute Coronary Syndrome |
ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry
| Study Type : | Observational |
| Actual Enrollment : | 1006 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry |
| Study Start Date : | December 2011 |
| Actual Primary Completion Date : | August 2014 |
| Actual Study Completion Date : | August 2014 |
| Group/Cohort |
|---|
| one group (all patients) |
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 ]after collecting all Case Record Form
Secondary Outcome Measures :
- Description of reasons of premature withdrawal from the program. [ Time Frame: up to 12 months ]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 ]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 ]after collecting all Case Record Form
- Description of patients's needs in long term care of ACS. [ Time Frame: up to 12 months ]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 ]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 ]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 ]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 ]after collecting all Case Record Form
- Frequency of resource use according to the acceptance of the program. [ Time Frame: up to 12 months ]after collecting all Case Record Form
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490645
Locations
| Germany | |
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| Arnstadt, Germany | |
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| 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 | |
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| Wuerzburg, Germany | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Helmut Brasch, Prof. Dr. | AstraZeneca Germany | |
| Principal Investigator: | Franz Goss, Dr. med. | 80331 Munich, Germany |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01490645 History of Changes |
| Other Study ID Numbers: |
NIS-CDE-XXX-2011/1 NIS-CDE-XXX-2011/1 |
| First Posted: | December 13, 2011 Key Record Dates |
| Last Update Posted: | September 5, 2014 |
| Last Verified: | September 2014 |
Keywords provided by AstraZeneca:
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ACS patients participating in a SCP QoL after ACS ASC Patients's needs |
Additional relevant MeSH terms:
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Syndrome Acute Coronary Syndrome Disease Pathologic Processes |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |