Clinical trial NCT04887571: the PrEsentation, Rationale and Impact of reperFUSION for Acute Coronary Syndromes in Cape Town and the Garden Route Health District - the PERFUSION Registry
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
ST Elevated Myocardial Infarction
Non ST Elevation Myocardial Infarction
Unstable Angina
Keywords: Acute Coronary Syndrome
STEMI
NSTEMI
Unstable Angina
Sub-Saharan Africa
Cape Town
South Africa
Myocardial Infarction
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is designed to include adult patients from the Cape Metropole and the Garden Route Health District who present with acute coronary syndromes (STEMI, NSTEMI, or Unstable Angina).

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* signed written informed consent before any study recruitment; and
* male or female patients age ≥ 18 years of age; and
* a diagnosis of ACS (STEMI, NSTEMI or UA).

Exclusion Criteria:

* ACS absent within index admission; or
* refusal of consent

Primary outcomes:
measure: 1-year combined primary endpoint
timeFrame: 1 year
Secondary outcomes:
measure: cardiac adverse events
timeFrame: 1-year
measure: 1 month combined end point
timeFrame: 1-month
measure: 6 month combined end point
timeFrame: 6-month
measure: Compliance profile
timeFrame: 1-year
measure: Refusion time
timeFrame: 1-year
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
city: Cape Town
country: South Africa
facility: Victoria Hospital
state: Western Cape
city: Cape Town
country: South Africa
facility: New Somerset Hospital
state: Western Cape
city: George
country: South Africa
facility: George Hospital
state: Western Cape
Study officials:
affiliation: Groote Schuur Hospital
name: Mpiko Ntsekhe, PhD
role: PRINCIPAL_INVESTIGATOR
References: