Acute Coronary Syndrome Sri Lanka Audit Project

Acute Coronary Syndrome Clinical Trial

— ACSSLAP  

Official title:

Improving Care for Patients With Acute Coronary Syndrome: Acute Coronary Syndrome Sri Lanka Audit Project (ACSSLAP)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02893280
• Other study ID #: UC00101
• Status: Withdrawn
• Phase: N/A
• First received: August 29, 2016
• Last updated: September 15, 2016
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: University of Colombo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sri Lanka: Ministry of Healthcare & Nutrition
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Infarction
• Myocardial Infarction
• Non ST Elevation Myocardial Infarction
• ST Elevation Myocardial Infarction
• Syndrome
• Unstable Angina

Intervention

Drug:
• aspirin, clopidogrel, statin, enoxaparin, streptokinase
Acute coronary syndrome treatment

Locations

Country	Name	City	State
Sri Lanka	Faculty of Medicine	Colombo	Western Province

Sponsors (2)

Lead Sponsor	Collaborator
University of Colombo	Ministry of Health, Sri Lanka

Country where clinical trial is conducted

Sri Lanka, 

References & Publications (1)

Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):e344-426. doi: 10.1161/CIR.0000000000000134. Epub 2014 Sep 23. Erratum in: Circulation. 2014 Dec 23;130(25):e433-4. Dosage error in article text. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient management	To assess acute coronary sysndrome (ACS) patient management clinical practices island wide	From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay	No
Other	Health care resources utilization	To assess health care resources utilization for acute coronary syndrome patients island wide	From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay	No
Primary	Discharge, recovery or death after diagnosed acute coronary syndrome	Recovery, discharge or death after acute coronary syndrome management following admission to a hospital	From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay	No