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CompletedNCT01490645ProAcorUpdated Sep 5, 2014

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

An observational study in Acute Coronary Syndrome, sponsored by AstraZeneca. Completed at 45 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-05.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,006
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry

02

Conditions studied

  • Acute Coronary Syndrome

Keywords

  • ACS patients participating in a SCP
  • QoL after ACS
  • ASC Patients's needs
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 1,006 is above the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Regional centres / hospitals with a significant number of ACS patients

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,006 participants (actual)

Groups and cohorts

  • one group (all patients)
06

What researchers measure

Primary outcomes

  1. 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.

    after collecting all Case Record Form

    Time frame: up to 24 months

Secondary outcomes

  1. Description of reasons of premature withdrawal from the program.

    after collecting all Case Record Form

    Time frame: up to 12 months

  2. Description of changes in quality of life (QoL) during the period of 12 months.

    after collecting all Case Record Form

    Time frame: up to 12 months

  3. Description of acceptance of the program between subgroups (e.g. gender, risk scores, types of ACS, multimorbidity, medical treatment, therapy).

    after collecting all Case Record Form

    Time frame: up to 12 months

  4. Description of patients's needs in long term care of ACS.

    after collecting all Case Record Form

    Time frame: up to 12 months

  5. 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)).

    after collecting all Case Record Form

    Time frame: up to 12 months

  6. 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.

    after collecting all Case Record Form

    Time frame: up to 12 months

  7. Frequency of changes in ambulant treatment according to the acceptance of the program.

    after collecting all Case Record Form

    Time frame: up to 12 months

  8. Frequency of newly occurred symptomatic acute cardiac events according to the acceptance of the program.

    after collecting all Case Record Form

    Time frame: up to 12 months

  9. Frequency of resource use according to the acceptance of the program.

    after collecting all Case Record Form

    Time frame: up to 12 months

07

Study locations

45 sites
  • Research Site
    Arnstadt, Germany
  • Research Site
    Augsburg, Germany
  • Research Site
    Bad Soden, Germany
  • Research Site
    Berlin-Helersdorf, Germany
  • Research Site
    Berlin-Humbold, Germany
  • Research Site
    Berlin-Lichtenberg, Germany
  • Research Site
    Berlin-Neukoelln, Germany
  • Research Site
    Berlin-Pankow, Germany
  • Research Site
    Berlin-Spandau, Germany
  • Research Site
    Berlin, 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
    Duesseldorf, Germany
  • Research Site
    Flensburg, Germany
  • Research Site
    Frankfurt, Germany
  • Research Site
    Goettingen, Germany
  • Research Site
    Hamburg, Germany
  • Research Site
    Hilden, Germany
  • Research Site
    Hochberg, Germany
  • Research Site
    Hoexter, Germany
  • Research Site
    Karlstadt, Germany
  • Research Site
    Kassel, Germany
  • Research Site
    Kiel, Germany
  • Research Site
    Koeln, Germany
  • Research Site
    Lippstadt, Germany
  • Research Site
    Loerrach, Germany
  • Research Site
    Luenen, 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
    Ulm Donau, Germany
  • Research Site
    Ulm, Germany
  • Research Site
    Wesel, Germany
  • Research Site
    Wilster, Germany
  • Research Site
    Wuerzburg, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01490645
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Dec 13, 2011
Start date
Dec 2011
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Sep 5, 2014

Study contacts

Helmut Brasch, Prof. Dr.
study director · AstraZeneca Germany
Franz Goss, Dr. med.
principal investigator · 80331 Munich, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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