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

Acute Coronary Syndrome Clinical Trial

— ProAcor  

Official title:

ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490645
• Other study ID #: NIS-CDE-XXX-2011/1
• Secondary ID: NIS-CDE-XXX-2011
• Status: Completed
• Phase: N/A
• First received: December 9, 2011
• Last updated: September 4, 2014
• Start date: December 2011
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Description:

ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1006
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
Germany	Research Site	Arnstadt
Germany	Research Site	Augsburg
Germany	Research Site	Bad Soden
Germany	Research Site	Berlin
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	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
Germany	Research Site	Ulm Donau
Germany	Research Site	Wesel
Germany	Research Site	Wilster
Germany	Research Site	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Description of reasons of premature withdrawal from the program.	after collecting all Case Record Form	up to 12 months	No
Secondary	Description of changes in quality of life (QoL) during the period of 12 months.	after collecting all Case Record Form	up to 12 months	No
Secondary	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	up to 12 months	No
Secondary	Description of patients's needs in long term care of ACS.	after collecting all Case Record Form	up to 12 months	No
Secondary	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	up to 12 months	No
Secondary	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	up to 12 months	No
Secondary	Frequency of changes in ambulant treatment according to the acceptance of the program.	after collecting all Case Record Form	up to 12 months	No
Secondary	Frequency of newly occurred symptomatic acute cardiac events according to the acceptance of the program.	after collecting all Case Record Form	up to 12 months	No
Secondary	Frequency of resource use according to the acceptance of the program.	after collecting all Case Record Form	up to 12 months	No