Clinical trial NCT01490645: A NIS Registry of the Prospective Structured Care In Acute Coronary Syndrome
Official title: ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: ACS patients participating in a SCP
QoL after ACS
ASC Patients's needs
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-12-13
Enrollment: 1006
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Regional centres / hospitals with a significant number of ACS patients

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.

Detailed description: ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry

Eligibility 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

Primary outcomes:
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.
timeFrame: up to 24 months
Secondary outcomes:
measure: Description of reasons of premature withdrawal from the program.
timeFrame: up to 12 months
measure: Description of changes in quality of life (QoL) during the period of 12 months.
timeFrame: up to 12 months
measure: Description of acceptance of the program between subgroups (e.g. gender, risk scores, types of ACS, multimorbidity, medical treatment, therapy).
timeFrame: up to 12 months
measure: Description of patients's needs in long term care of ACS.
timeFrame: up to 12 months
measure: 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)).
timeFrame: up to 12 months
measure: 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.
timeFrame: up to 12 months
measure: Frequency of changes in ambulant treatment according to the acceptance of the program.
timeFrame: up to 12 months
measure: Frequency of newly occurred symptomatic acute cardiac events according to the acceptance of the program.
timeFrame: up to 12 months
measure: Frequency of resource use according to the acceptance of the program.
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Arnstadt
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bad Soden
country: Germany
facility: Research Site
city: Berlin-Helersdorf
country: Germany
facility: Research Site
city: Berlin-Humbold
country: Germany
facility: Research Site
city: Berlin-Lichtenberg
country: Germany
facility: Research Site
city: Berlin-Neukoelln
country: Germany
facility: Research Site
city: Berlin-Pankow
country: Germany
facility: Research Site
city: Berlin-Spandau
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Buchholz
country: Germany
facility: Research Site
city: Chemnitz
country: Germany
facility: Research Site
city: Coburg
country: Germany
facility: Research Site
city: Coswig
country: Germany
facility: Research Site
city: Cottbus
country: Germany
facility: Research Site
city: Dessau-Rosslau
country: Germany
facility: Research Site
city: Dinslaken
country: Germany
facility: Research Site
city: Duesseldorf
country: Germany
facility: Research Site
city: Flensburg
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Goettingen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hilden
country: Germany
facility: Research Site
city: Hochberg
country: Germany
facility: Research Site
city: Hoexter
country: Germany
facility: Research Site
city: Karlstadt
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Koeln
country: Germany
facility: Research Site
city: Lippstadt
country: Germany
facility: Research Site
city: Loerrach
country: Germany
facility: Research Site
city: Luenen
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Merseburg
country: Germany
facility: Research Site
city: Nordhausen
country: Germany
facility: Research Site
city: Querfurt
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Stralsund
country: Germany
facility: Research Site
city: Templin
country: Germany
facility: Research Site
city: Ulm Donau
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Wesel
country: Germany
facility: Research Site
city: Wilster
country: Germany
facility: Research Site
city: Wuerzburg
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca Germany
name: Helmut Brasch, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: 80331 Munich, Germany
name: Franz Goss, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: