A NIS Registry of the Prospective Structured Care In Acute Coronary Syndrome (ProAcor)
This study is currently recruiting participants.
Verified April 2013 by AstraZeneca
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01490645
First received: December 9, 2011
Last updated: April 26, 2013
Last verified: April 2013
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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
| Estimated Enrollment: | 1000 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490645
Contacts
| Contact: Karin Schiene | +49 (0) 800 22 88 66 0 | Karin.schiene@astrazeneca.com |
Locations
| Germany | |
| Research Site | Recruiting |
| Arnstadt, Germany | |
| Research Site | Recruiting |
| Augsburg, Germany | |
| Research Site | Recruiting |
| Bad Soden, Germany | |
| Research Site | Recruiting |
| Berlin, Germany | |
| Research Site | Recruiting |
| Bonn, Germany | |
| Research Site | Recruiting |
| Buchholz, Germany | |
| Research Site | Recruiting |
| Chemnitz, Germany | |
| Research Site | Recruiting |
| Coburg, Germany | |
| Research Site | Recruiting |
| Coswig, Germany | |
| Research Site | Recruiting |
| Cottbus, Germany | |
| Research Site | Active, not recruiting |
| Dessau-Rosslau, Germany | |
| Research Site | Active, not recruiting |
| Dinslaken, Germany | |
| Research Site | Recruiting |
| Dusseldorf, Germany | |
| Research Site | Recruiting |
| Flensburg, Germany | |
| Research Site | Recruiting |
| Frankfurt, Germany | |
| Research Site | Recruiting |
| Gottingen, Germany | |
| Research Site | Recruiting |
| Hamburg, Germany | |
| Research Site | Active, not recruiting |
| Hilden, Germany | |
| Research Site | Active, not recruiting |
| Hochberg, Germany | |
| Research Site | Recruiting |
| Hoxter, Germany | |
| Research Site | Active, not recruiting |
| Karlstadt, Germany | |
| Research Site | Recruiting |
| Kassel, Germany | |
| Research Site | Recruiting |
| Kiel, Germany | |
| Research Site | Recruiting |
| Koln, Germany | |
| Research Site | Recruiting |
| Lippstadt, Germany | |
| Research Site | Recruiting |
| Lorrach, Germany | |
| Research Site | Recruiting |
| Lunen, Germany | |
| Research Site | Recruiting |
| Magdeburg, Germany | |
| Research Site | Recruiting |
| Merseburg, Germany | |
| Research Site | Not yet recruiting |
| Munchen, Germany | |
| Research Site | Recruiting |
| Nordhausen, Germany | |
| Research Site | Active, not recruiting |
| Querfurt, Germany | |
| Research Site | Recruiting |
| Regensburg, Germany | |
| Research Site | Recruiting |
| Stralsund, Germany | |
| Research Site | Active, not recruiting |
| Templin, Germany | |
| Research Site | Not yet recruiting |
| Tubingen, Germany | |
| Research Site | Recruiting |
| Ullm/Donau, Germany | |
| Research Site | Recruiting |
| Wesel, Germany | |
| Research Site | Active, not recruiting |
| Wilster, Germany | |
| Research Site | Recruiting |
| Wurzburg, 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
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01490645 History of Changes |
| Other Study ID Numbers: | NIS-CDE-XXX-2011/1, NIS-CDE-XXX-2011/1 |
| Study First Received: | December 9, 2011 |
| Last Updated: | April 26, 2013 |
| 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:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013