Acute Coronary SyndromeACSSLAPNCT02893280
Acute Coronary Syndrome Sri Lanka Audit Project
An observational study of Acute Coronary Syndrome and Unstable Angina, run by University of Colombo at 1 site in Sri Lanka.
Trial summary
ACSSLAP is the first island wide audit project in Sri Lanka on ACS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Unstable Angina, Non ST Elevation Myocardial Infarction
- What is being tested?
- aspirin, clopidogrel, statin, enoxaparin, streptokinase
- How many people
- 0 participants
- Where
- 1 siteSri Lanka
- Study dates
- Apr 2015to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This audit will be conducted representing the hierarchy of health care delivery system representing tertiary units, teaching hospitals, district general hospitals up to base hospital level where at least a physician is available. Sample size will be considered based on the number of admissions to each hospital. Minimum number from each hospital will be 30. This number was selected as according to International Network on Rational Use of Drugs (INRUD) guidelines of the World Health Organization, a minimum of 30 prescriptions are recommended from each unit and a minimum of 20 units when auditing prescription data to give a minimum of 600 prescription encounters.
Who may be able to join
- -Patients who are diagnosed with acute coronary syndrome before/after admission to the hospital.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Care for Patients With Acute Coronary Syndrome: Acute Coronary Syndrome Sri Lanka Audit Project (ACSSLAP)
ACSSLAP is the first island wide audit project in Sri Lanka on ACS.
Read the 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
- Conditions
- Acute Coronary Syndrome, Unstable Angina, Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction
- Being tested
- aspirin, clopidogrel, statin, enoxaparin, streptokinase
- Medical subject headings
- Acute Coronary Syndrome, Angina, Unstable, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin, clopidogrel, statin, enoxaparin, streptokinaseDrug
Also called Alteplase
Acute coronary syndrome treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge, recovery or death after diagnosed acute coronary syndrome
Recovery, discharge or death after acute coronary syndrome management following admission to a hospital
Measured: From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startApr 2015
- Primary completionJul 2016
- Study completionAug 2016
Why it stopped: Due to an incompatibility with the local procedures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colombo
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Sri Lanka
- Responsible party
- Principal investigator, Vipula R Bataduwaarachchi, University of Colombo
- Investigators
- Priyadarshani Galappatthy, MD, Principal investigator, Department of Pharmacology, Faculty of Medicine, University of Colombo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893280
- Sponsor's protocol ID
- UC00101
- Acronym
- ACSSLAP
- Status last verified
- Sep 2016
- First submitted
- 29 Aug 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be documented on September 17th, 2016
Publications
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. No abstract available.
PubMed 25249585
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care for Patients With Acute Coronary Syndrome: Acute Coronary Syndrome Sri Lanka Audit Project (ACSSLAP)
- ClinicalTrials.gov ID
- NCT02893280
- Acronym / sponsor ID
- ACSSLAP / UC00101
- Conditions
- Acute Coronary Syndrome, Unstable Angina, Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to an incompatibility with the local procedures
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ColomboUniversity, hospital or other
- Collaborators
- Ministry of Health, Sri Lanka
- Study start
- Apr 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ACSSLAP is the first island wide audit project in Sri Lanka on ACS.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This audit will be conducted representing the hierarchy of health care delivery system representing tertiary units, teaching hospitals, district general hospitals up to base hospital level where at least a physician is available. Sample size will be considered based on the number of admissions to each hospital. Minimum number from each hospital will be 30. This number was selected as according to International Network on Rational Use of Drugs (INRUD) guidelines of the World Health Organization, a minimum of 30 prescriptions are recommended from each unit and a minimum of 20 units when auditing prescription data to give a minimum of 600 prescription encounters.
Key inclusion criteria (1 listed)
- -Patients who are diagnosed with acute coronary syndrome before/after admission to the hospital.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin, clopidogrel, statin, enoxaparin, streptokinaseAlso: AlteplaseAcute coronary syndrome treatment | Drug | – |
Primary outcome
Discharge, recovery or death after diagnosed acute coronary syndrome
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Background: PubMed 25249585Amsterdam 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. No abstract available.
- Individual participant dataSharing planned: Yes. Data will be documented on September 17th, 2016
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priyadarshani Galappatthy, MD principal investigator
Department of Pharmacology, Faculty of Medicine, University of Colombo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Unstable Angina, run by University of Colombo at 1 site in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharge, recovery or death after diagnosed acute coronary syndrome (time frame: From the diagnosis of acute coronary syndrome up to 4 weeks of the hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.