Cardiology
Conditions
Interventions
Cardiflo device
Sponsors
Council for Scientific and Industrial Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. Male or female, age =18 years at the time of signing informed consent. 3. LDL = 190 mg/dl •ASCVD >10 if LDL =70 mg/dL (as per ACC/AHA guidelines) triglycerides >500 mg/dl 4. ASCVD risk score <7.5% with LDL < 190 mg/dl OR •ASCVD risk score 7.5-10% with LDL < 160 mg/dl OR •ASCVD risk score 10-15% with LDL <130 mg/dl 5. History of clinical ASCVD (heart attack, stroke) as per by 2013 ACC/AHA Cholesterol Guidelines 6. At least one of the below conditions (a-d): a) Coronary heart disease defined as at least one of the following: I. Prior myocardial infarction II. Prior coronary revascularisation procedure III. =50% stenosis in coronary artery documented by cardiac catheterisation or CT IV. coronary angiography V. Coronary heart disease with ischaemia documented by stress test with any VI. imaging modality b) Cerebrovascular disease defined as at least one of the following: I. Prior stroke II. Prior carotid artery revascularisation procedure III. =50% stenosis in carotid artery documented by X-ray angiography, MR IV. angiography, CT angiography or Doppler ultrasound c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following: I. Intermittent claudication with an Ankle-brachial index (ABI) < 0.85 at rest II. Intermittent claudication with a =50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound III. Prior peripheral artery (excluding carotid) revascularization procedure IV. Lower extremity amputation at or above ankle due to atherosclerotic disease V. (Excluding e.g., trauma or osteomyelitis) d) Chronic kidney disease defined as: eGFR < 60 mL/min/1.73 m2
Exclusion criteria
Exclusion criteria: 1. Pregnancy, breastfeeding, or refusal to use contraception (for women of reproductive potential). 2. Knowledge or suspicion of pregnancy 3. Vasoactive medication (e.g., nitro) during the 12 hours prior to the exam
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Retention in care | — |
Secondary
| Measure | Time frame |
|---|---|
| 2) Incidence of MACE (major adverse cardiovascular events such as MI, stroke, cardiovascular death) | — |
Countries
South Africa
Contacts
Public ContactMathilda Mennen
Study Doctor
Outcome results
None listed