A NIS Registry of the Prospective Structured Care In Acute Coronary Syndrome (ProAcor)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01490645
First received: December 9, 2011
Last updated: February 26, 2014
Last verified: February 2014
  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
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

Locations
Germany
Research Site
Arnstadt, Germany
Research Site
Augsburg, Germany
Research Site
Bad Soden, Germany
Research Site
Berlin, Germany
Research Site
Berlin/Hellersdorf, Germany
Research Site
Berlin/Humbold, Germany
Research Site
Berlin/Lichtenberg, Germany
Research Site
Berlin/Neukolln, Germany
Research Site
Berlin/Pankow, Germany
Research Site
Berlin/Spandau, Germany
Research Site
Bonn, Germany
Research Site
Buchholz, Germany
Research Site
Chemnitz, Germany
Research Site
Coburg, Germany
Research Site
Coswig, Germany
Research Site
Cottbus, Germany
Research Site
Dessau-Rosslau, Germany
Research Site
Dinslaken, Germany
Research Site
Dusseldorf, Germany
Research Site
Flensburg, Germany
Research Site
Frankfurt, Germany
Research Site
Gottingen, Germany
Research Site
Hamburg, Germany
Research Site
Hilden, Germany
Research Site
Hochberg, Germany
Research Site
Hoxter, Germany
Research Site
Karlstadt, Germany
Research Site
Kassel, Germany
Research Site
Kiel, Germany
Research Site
Koln, Germany
Research Site
Lippstadt, Germany
Research Site
Lorrach, Germany
Research Site
Lunen, Germany
Research Site
Magdeburg, Germany
Research Site
Merseburg, Germany
Research Site
Nordhausen, Germany
Research Site
Querfurt, Germany
Research Site
Regensburg, Germany
Research Site
Stralsund, Germany
Research Site
Templin, Germany
Research Site
Ullm/Donau, Germany
Research Site
Ulm, Germany
Research Site
Wesel, Germany
Research Site
Wilster, Germany
Research Site
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: February 26, 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:
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 April 17, 2014