Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04887571
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2021-05-05
Brief Title:
the PrEsentation Rationale and Impact of reperFUSION for Acute Coronary Syndromes in Cape Town and the Garden Route Health District - the PERFUSION Registry
Sponsor:
University of Cape Town
Organization:
University of Cape Town
Study Overview
Official Title:
the PrEsentation Rationale and Impact of reperFUSION for Acute Coronary Syndromes in Cape Town and the Garden Route Health District - the PERFUSION Registry
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERFUSION
Brief Summary:
The global burden and threat of non-communicable diseases NCDs have become a major health challenge that undermines social and economic development throughout the world Cardiovascular disease including acute coronary syndromes ACS currently accounts for 179 million deaths a year Low and middle-income countries such as those in sub-Saharan Africa SSA have undergone a rapid epidemiological transition over the last few decades and now have a burden of disease increasingly dominated by NCDs The global burden of disease report for 2017 revealed a 714 increase in cardiovascular disease in SSA predicting a large increase in mortality Unfortunately reliable population-level data regarding the incidence prevalence and demographics of ACS in SSA are limited The investigators propose to set up and conduct a multi-centre prospective observational registry to describe the demographics clinical characteristics presentation management and outcomes of patients admitted with ACS in Cape Town and the Garden Route Health District Western Cape Province South Africa The registry is designed to shed insight on the current burden and impact of atherosclerotic cardiovascular disease in the Western Cape
Detailed Description:
The investigators propose to set up and conduct a multi-centre prospective observational registry to describe the demographics clinical characteristics presentation management and outcomes of patients admitted with ACS in Cape Town and the Garden Route Health District Western Cape Province South Africa
The aims of this prospective multi-centre registry are to describe the burden demographics risk factor profile clinical course management and outcomes of patients presenting with ACS across the Cape Town metropole and the Garden Route Health District The registry will be called the PrEsentation Rationale and impact of reperFUSION for Acute Coronary Syndromes in Cape Town - the PERFUSION registry It will be designed to determine the feasibility of conducting a large multi-centre Acute Coronary Syndrome registry in South Africa
Primary Objectives
1 to enrol consecutive patients presenting with acute coronary syndromes from designated participating sites
2 to describe the demographic and risk factor profile of participants with ACS
3 to describe the burden of patients presenting with ACS in the Cape Town metropole and the Garden Route Health District
4 to describe the management of patients with ACS and assess compliance with current South African guidelines
5 to describe the one month six-month and 12-month outcomes with regard to all-cause mortality hospitalisation and major adverse cardiac events recurrence of ACS heart failure stroke and ventricular tachy-arrythmias
Methods
Registry design The PERFUSION registry will enrol consecutive consenting adults 18 years admitted to participating healthcare centres in the cities of Cape Town and the Garden Route Health District Western Cape South Africa Depending on available capacity and resources the registry may be expanded to other healthcare centres in the Western Cape and other provinces of South Africa
As this is fundamentally an observational study all participants enrolled will receive management based on local standard of care guidelines Participant management will not be affected by recruitment into this study By using the hub spoke pre-spoke model all patients presenting with an ACS to a designated public healthcare care facility in the Cape Town metropole and the Garden Route Health District will be screened for study eligibility criteria Screening will occur at hub and spoke levels only Designated site PIs will identify potential study participants meeting eligibility criteria during their index ACS admission Once screened according to the studys inclusion and exclusion criteria potential participants will be consented for study participation Clinical information fulfilling pre-defined registry variables will be entered into a standardised paper-based case report form CRF or electronic CFR and uploaded onto a secure data collection web application called the Research Electronic Data Capture REDCap by the studys data capturers Upon data entry participants will be immediately assigned a unique identifier generated by REDCap to maintain confidentiality The REDCap database is governed by strict password-controlled access assigned only to approved study team members
Data collection
The database variables collected for this registry are in line with the American College of Cardiology Foundation American Heart Association Task Force on Key Data Elements These include data pertaining to patient demographics comorbidities and prior medication index ACS presentation at the pre-spoke spoke or hub level ECG features echocardiography laboratory investigations management and treatment received at the pre-spoke spoke or hub level angiography complications of therapies and interventions and outcomes in-hospital 1 month 6 month and 1 year
To limit an additional burden on the healthcare system the investigators plan on following-up participants electronically using the Western Cape Provincial Health Data Centre PHDC and Single Patient Viewer SPV online tool over a period of 1-year after the index ACS presentation The investigators have received both HREC and provincial permission for the utilisation of data from the PHDC and SPV for this research Follow-up data will be uploaded directly onto REDCap and anonymised
The key outcomes of interest will include
1 mortality all-cause and cardiovascular
2 recurrent and re-infarction myocardial infarction
3 new-onset heart failure and arrhythmia complications
4 cerebrovascular events
5 major bleeding events
6 repeat hospitalisation for any cause
The extended list of all variables collected will be found on the registrys CRF
Benefits of registry participation
Although there are no direct study benefits to the participant the study will indirectly improve our knowledge of acute coronary syndromes in South Africa By providing local reliable evidence in our resource constraint environment the investigators may improve the standard of care provided to patients with ACS and possibly identify novel cardioprotective strategies that may help reduce the burden of ACS in South Africa
Risk of registry participation
The PERFUSION registry is designed to be a prospective observational registry Participant enrolment will not deviate management from local standard of care guidelines There is no investigational medicinal product drug or device practised in this protocol Participation in this study has no physical psychological social economic or legal risk For people who do not want to take part in the study routine standard of care will be maintained
The aims of this prospective multi-centre registry are to describe the burden demographics risk factor profile clinical course management and outcomes of patients presenting with ACS across the Cape Town metropole and the Garden Route Health District The registry will be called the PrEsentation Rationale and impact of reperFUSION for Acute Coronary Syndromes in Cape Town - the PERFUSION registry It will be designed to determine the feasibility of conducting a large multi-centre Acute Coronary Syndrome registry in South Africa
Primary Objectives
1 to enrol consecutive patients presenting with acute coronary syndromes from designated participating sites
2 to describe the demographic and risk factor profile of participants with ACS
3 to describe the burden of patients presenting with ACS in the Cape Town metropole and the Garden Route Health District
4 to describe the management of patients with ACS and assess compliance with current South African guidelines
5 to describe the one month six-month and 12-month outcomes with regard to all-cause mortality hospitalisation and major adverse cardiac events recurrence of ACS heart failure stroke and ventricular tachy-arrythmias
Methods
Registry design The PERFUSION registry will enrol consecutive consenting adults 18 years admitted to participating healthcare centres in the cities of Cape Town and the Garden Route Health District Western Cape South Africa Depending on available capacity and resources the registry may be expanded to other healthcare centres in the Western Cape and other provinces of South Africa
As this is fundamentally an observational study all participants enrolled will receive management based on local standard of care guidelines Participant management will not be affected by recruitment into this study By using the hub spoke pre-spoke model all patients presenting with an ACS to a designated public healthcare care facility in the Cape Town metropole and the Garden Route Health District will be screened for study eligibility criteria Screening will occur at hub and spoke levels only Designated site PIs will identify potential study participants meeting eligibility criteria during their index ACS admission Once screened according to the studys inclusion and exclusion criteria potential participants will be consented for study participation Clinical information fulfilling pre-defined registry variables will be entered into a standardised paper-based case report form CRF or electronic CFR and uploaded onto a secure data collection web application called the Research Electronic Data Capture REDCap by the studys data capturers Upon data entry participants will be immediately assigned a unique identifier generated by REDCap to maintain confidentiality The REDCap database is governed by strict password-controlled access assigned only to approved study team members
Data collection
The database variables collected for this registry are in line with the American College of Cardiology Foundation American Heart Association Task Force on Key Data Elements These include data pertaining to patient demographics comorbidities and prior medication index ACS presentation at the pre-spoke spoke or hub level ECG features echocardiography laboratory investigations management and treatment received at the pre-spoke spoke or hub level angiography complications of therapies and interventions and outcomes in-hospital 1 month 6 month and 1 year
To limit an additional burden on the healthcare system the investigators plan on following-up participants electronically using the Western Cape Provincial Health Data Centre PHDC and Single Patient Viewer SPV online tool over a period of 1-year after the index ACS presentation The investigators have received both HREC and provincial permission for the utilisation of data from the PHDC and SPV for this research Follow-up data will be uploaded directly onto REDCap and anonymised
The key outcomes of interest will include
1 mortality all-cause and cardiovascular
2 recurrent and re-infarction myocardial infarction
3 new-onset heart failure and arrhythmia complications
4 cerebrovascular events
5 major bleeding events
6 repeat hospitalisation for any cause
The extended list of all variables collected will be found on the registrys CRF
Benefits of registry participation
Although there are no direct study benefits to the participant the study will indirectly improve our knowledge of acute coronary syndromes in South Africa By providing local reliable evidence in our resource constraint environment the investigators may improve the standard of care provided to patients with ACS and possibly identify novel cardioprotective strategies that may help reduce the burden of ACS in South Africa
Risk of registry participation
The PERFUSION registry is designed to be a prospective observational registry Participant enrolment will not deviate management from local standard of care guidelines There is no investigational medicinal product drug or device practised in this protocol Participation in this study has no physical psychological social economic or legal risk For people who do not want to take part in the study routine standard of care will be maintained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None