ACSSLAP: Acute Coronary Syndrome Sri Lanka Audit Project

Sponsor
University of Colombo (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02893280
Collaborator
Ministry of Health, Sri Lanka (Other)
0
1
16
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Study Details

Study Description

Brief Summary

ACSSLAP is the first island wide audit project in Sri Lanka on ACS.

Condition or Disease Intervention/Treatment Phase
  • Drug: aspirin, clopidogrel, statin, enoxaparin, streptokinase

Detailed Description

Acute coronary syndrome is a leading cause of morbidity and mortality in the world. Even though up-to-date epidemiological data are not available, as per the institutional level experiences this is not differ much in the local settings. Having a free health care system, government of Sri Lanka has to allocate billions of funds and resources from the annual budget for the maintenance of health care system. Being a developing nation this is a considerable burden to the economy of the country. However, prioritization during resource allocation will prevent mal-distribution of limited resources.

Health care system in Sri Lanka should deliver free as well as quality care to the nation. However, lack of updated guidelines in Sri Lanka for the management for acute coronary syndrome (ACS) is a drawback. American College of Cardiology (ACC) and the European Heart Association (EHA) have developed evidence based and most up to date guidelines to standardize clinical practices in the management of ACS. It is recommended to adhere to local or International guidelines to deliver optimal and quality care to ACS patients.

In Sri Lanka, no audits have been conducted in the health sector in relation to patient management practices in the past. Even though institutional level audits have been carried out time to time for the purpose of allocating medicines and other diagnostic resources, island wide large scale audits have not been carried out. Therefore, conducting an audit on health recourse allocation and patient management clinical practices has become a high priority.

Investigators selected ACS as the most important clinical discipline to conduct an audit based on the institutional level data. This audit is included as a well-designed set of clinical criteria derived from the Myocardial Ischemia National Audit Project (MINAP) in UK, SNAPSHOT ACS study in Australia and New Zealand, American College of Cardiology and European Health Association guidelines. These criteria have been extensively reviewed by a panel of cardiologists and physicians to customize it according to the local requirements.

This project will be Coordinated by the Department of Pharmacology, Faculty of Medicine, University of Colombo in collaboration with the Sri Lanka Heart Association, Ceylon College of Physicians and will be carried out through the Quality and safety Unit of the Ministry of Health, Sri Lanka. Funding is sought from the Ministry of Health

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Improving Care for Patients With Acute Coronary Syndrome: Acute Coronary Syndrome Sri Lanka Audit Project (ACSSLAP)
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Outcome Measures

Primary Outcome Measures

  1. Discharge, recovery or death after diagnosed acute coronary syndrome [From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay]

    Recovery, discharge or death after acute coronary syndrome management following admission to a hospital

Other Outcome Measures

  1. Patient management [From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay]

    To assess acute coronary sysndrome (ACS) patient management clinical practices island wide

  2. Health care resources utilization [From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay]

    To assess health care resources utilization for acute coronary syndrome patients island wide

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

-Patients who are diagnosed with acute coronary syndrome before/after admission to the hospital.

Exclusion Criteria:
  • Patient who refuse to give consent

  • Patients who are less than 18 years of age

  • Patients whose diagnosis later changed to another diagnosis

  • Patient who are enrolled in any other study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Colombo Western Province Sri Lanka 80200

Sponsors and Collaborators

  • University of Colombo
  • Ministry of Health, Sri Lanka

Investigators

  • Principal Investigator: Priyadarshani Galappatthy, MD, Department of Pharmacology, Faculty of Medicine, University of Colombo

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Vipula R Bataduwaarachchi, Lecturer in Pharmacology and Pharmacy, University of Colombo
ClinicalTrials.gov Identifier:
NCT02893280
Other Study ID Numbers:
  • UC00101
First Posted:
Sep 8, 2016
Last Update Posted:
Sep 16, 2016
Last Verified:
Sep 1, 2016

Study Results

No Results Posted as of Sep 16, 2016