Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04887571 |
| Other study ID # |
PERFUSION |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
May 31, 2022 |
Study information
| Verified date |
June 2023 |
| Source |
University of Cape Town |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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 17.9
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 71.4% 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.
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 PI's will
identify potential study participants meeting eligibility criteria during their index ACS
admission. Once screened according to the study's 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 study's 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 registry's 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.
