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

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT01490645
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-09
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-13
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1006

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	up to 24 months	after collecting all Case Record Form

Secondary Outcome Measures

Name	Time	Method
Description of changes in quality of life (QoL) during the period of 12 months.	up to 12 months	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)).	up to 12 months	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.	up to 12 months	after collecting all Case Record Form
Frequency of changes in ambulant treatment according to the acceptance of the program.	up to 12 months	after collecting all Case Record Form
Description of reasons of premature withdrawal from the program.	up to 12 months	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).	up to 12 months	after collecting all Case Record Form
Description of patients's needs in long term care of ACS.	up to 12 months	after collecting all Case Record Form
Frequency of newly occurred symptomatic acute cardiac events according to the acceptance of the program.	up to 12 months	after collecting all Case Record Form
Frequency of resource use according to the acceptance of the program.	up to 12 months	after collecting all Case Record Form

Trial Locations

Locations (1)

Research Site; 🇩🇪 Wuerzburg, Germany