the PrEsentation, Rationale and Impact of reperFUSION for Acute Coronary Syndromes in Cape Town and the Garden Route Health District - the PERFUSION Registry

NCT04887571 | Completed DMC

• 1 other identifier: PERFUSION
• Study Type: observational
• Target: 870
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• 1-year combined primary endpoint

  all-cause death, cardiac death, re-hospitalisation myocardial infarction, cerebrovascular accident

  1 year

Secondary Outcomes (5)

• cardiac adverse events

  1-year

• 1 month combined end point

  1-month

• 6 month combined end point

  6-month

• Compliance profile

  1-year

• Refusion time

  1-year

Study Arms (1)

Observational ACS Registry

All consecutive adult patients in the Cape Metropole and the Garden Route Health District with an acute coronary syndrome will be recruited into the PERFUSION registry across the study duration.

Other: No Intervention - Observational Registry

Interventions

No Intervention - Observational Registry OTHER

All consecutive adult patients in the Cape Metropole and the Garden Route Health District with an Acute coronary syndrome (STEMI, NSTEMI, Unstable Angina) will be recruited into the PERFUSION Registry.

Observational ACS Registry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (4)

Groote Schuur Hospital

Cape Town, Western Cape, 7295, South Africa

Location

Victoria Hospital

Cape Town, Western Cape, 7800, South Africa

Location

New Somerset Hospital

Cape Town, Western Cape, 8001, South Africa

Location

George Hospital

George, Western Cape, 6529, South Africa

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Angina, Unstable; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mpiko Ntsekhe, PhD

  Groote Schuur Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 14, 2021
• Study Start: February 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

ZA (4)