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Completed

NCT Number: NCT01490645

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Arnstadt, Germany

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About this study

ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    Time frame: up to 24 months

    after collecting all Case Record Form

Secondary outcomes

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

    Time frame: up to 12 months

    after collecting all Case Record Form

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

    Time frame: up to 12 months

    after collecting all Case Record Form

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

    Time frame: up to 12 months

    after collecting all Case Record Form

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

    Time frame: up to 12 months

    after collecting all Case Record Form

  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)).

    Time frame: up to 12 months

    after collecting all Case Record Form

  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.

    Time frame: up to 12 months

    after collecting all Case Record Form

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

    Time frame: up to 12 months

    after collecting all Case Record Form

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

    Time frame: up to 12 months

    after collecting all Case Record Form

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

    Time frame: up to 12 months

    after collecting all Case Record Form

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry

Acronym: ProAcor

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2011
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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