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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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01490645
First received: December 9, 2011
Last updated: April 26, 2013
Last verified: April 2013
History of Changes

December 9, 2011
April 26, 2013
December 2011
April 2014   (final data collection date for 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 ] [ Designated as safety issue: No ]
after collecting all Case Record Form
Same as current
Complete list of historical versions of study NCT01490645 on ClinicalTrials.gov Archive Site
  • 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
  • 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 Lipoproteine (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
Not Provided
Not Provided
 
A NIS Registry of the Prospective Structured Care In Acute Coronary Syndrome
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.

ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Regional centres / hospitals with a significant number of ACS patients
Acute Coronary Syndrome
Not Provided
one group (all patients)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Karin Schiene +49 (0) 800 22 88 66 0 Karin.schiene@astrazeneca.com
Germany
 
NCT01490645
NIS-CDE-XXX-2011/1, NIS-CDE-XXX-2011/1
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Helmut Brasch, Prof. Dr. AstraZeneca Germany
Principal Investigator: Franz Goss, Dr. med. 80331 Munich, Germany
AstraZeneca
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP