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

NCT01490645 | Completed

• 1 other identifier: NIS-CDE-XXX-2011/1
• Study Type: observational
• Target: 1,006
• Locations: 1 country
• Sites: 45

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.

Conditions

Acute Coronary Syndrome

Keywords

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

Outcome Measures

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

  up to 24 months

Secondary Outcomes (9)

• Description of reasons of premature withdrawal from the program.

  up to 12 months

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

  up to 12 months

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

  up to 12 months

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

  up to 12 months

• 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)).

  up to 12 months

Study Arms (1)

one group (all patients)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Regional centres / hospitals with a significant number of ACS patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (45)

Research Site

Arnstadt, Germany

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Augsburg, Germany

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Bad Soden, Germany

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Berlin, Germany

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Berlin-Helersdorf, Germany

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Berlin-Humbold, Germany

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Berlin-Pankow, Germany

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Berlin-Spandau, 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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Cologne, Germany

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Coswig, Germany

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Cottbus, Germany

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Dessau, Germany

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Dinslaken, Germany

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Düsseldorf, Germany

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Flensburg, Germany

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Frankfurt, Germany

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Göttingen, Germany

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Hamburg, Germany

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Hilden, Germany

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Höchberg, Germany

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Höxter, Germany

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Karlstadt am Main, Germany

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Kassel, Germany

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Kiel, Germany

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Lichtenberg, Germany

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Lippstadt, Germany

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Loerrach, Germany

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Lünen, Germany

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Magdeburg, Germany

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Merseburg, Germany

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Neukölln, 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, Germany

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Ulm Donau, Germany

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Wesel, Germany

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Wilster, Germany

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Würzburg, Germany

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MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Helmut Brasch, Prof. Dr.

  AstraZeneca Germany

  STUDY DIRECTOR

• Franz Goss, Dr. med.

  80331 Munich, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 13, 2011
• Study Start: December 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 5, 2014

Record last verified: 2014-09

Locations

DE (45)