NCT04604353Completed
Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring
Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring in at Risk Patients: Comparison With Coronary Computed Tomography
Source: ClinicalTrials.gov · Last updated 22 Aug 2024
Brief summary (registry, in English)
The overall goal of this study is to develop a combined polygenic risk score (PRS) and metabolic risk score (MRS) and determine its impact on selecting community members for CCS. The trial component of this study will compare the use of these scores to motivate people to adhere to therapy, an ongoing challenge for clinicians, by providing feedback in a meaningful form to both the clinicians and the patients.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1059 (actual)
- First submitted
- 19 Oct 2020
- Start date
- 7 Dec 2020
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Baker Heart and Diabetes Institute
- Diseases
- Coronary artery disease
- NCT number
- NCT04604353
What you commit to
- Study type: Interventional
- Participants enrolled: 1059
- From 7 Dec 2020 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intolerance of statins or currently on statins for any length of time
Other illness
- Symptomatic coronary, cerebrovascular, or peripheral vascular disease
- Pre-existing muscle disease (eg polymyositis, fibromyalgia) - this may be confused with myalgia from statins
- Patients on drugs that increase the risk of myopathy/rhabdomyolysis such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV/hepatitis C protease inhibitors)
- Major systemic illness eg. malignancy; rheumatoid arthritis
- Poorly controlled hypertension: SBP\> 200 and or DBP \> 100
- Severe psychiatric disorder (eg bipolar depression; psychosis)
Lab values
- Chronic kidney disease on haemodialysis (because of vascular calcification) or GFR \<50ml/min per 1.73m2 using the Modification of Diet in Renal Disease (MDRD) formula
- Patients eligible for treatment based on current PBS thresholds TC \>7.5 mmol/l and other criteria (see below).
Other
- Atrial fibrillation (interferes with CTCA)
- Inability to provide informed consent
- Women of child bearing potential (due to performance of CT)
- Patients eligible for treatment based on current Australian guidelines (5 year risk \>15%)
Who the study is looking for
- Asymptomatic subjects age 40-70y
- Statin naïve
- TC ≤ 6.5 mmol/L and LDLC \<5 mmol/L, and
- 5 year Australian risk ≥2%.
Age in the registry: 40 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baker Heart and Diabetes Institute Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.