Abstract
BackgroundOne of the most serious secondary manifestations of Cardiovascular Disease (CVD) is coronary atherosclerosis. This study aimed to evaluate whether aged garlic extract (AGE) can influence coronary artery calcification (CAC) and to predict the individual effect of AGE using a standard process for data mining (CRISP–DM).MethodThis was a single-center parallel randomized controlled study in a university hospital in Europe. Patients were randomized, in a double-blind manner, through a computer-generated randomization chart. Patients with a Framingham risk score ≥ 10 after CT scan (n = 104) were randomized to an intake of placebo or AGE (2400 mg daily) for 1 year.Main outcome measures were changes in CAC score and secondary outcome measures changes in blood pressure, fasting blood glucose, blood lipids and inflammatory biomarkers.Result104 patients were randomized and 46 in the active group and 47 in the placebo group were analyzed. There was a significant (p < 0.05) change in CAC progression (OR: 2.95 [1.05–8.27]), blood glucose (OR: 3.1 [1.09–8.85]) and IL-6 (OR 2.56 [1.00–6.53]) in favor of the active group. There was also a significant (p = 0.027) decrease in systolic blood pressure in the AGE group, from a mean of 148 (SD: 19) mmHg at 0 months, to 140 (SD: 15) mmHg after 12 months. The AGE Algorithm, at a selected probability cut-off value of 0.5, the accuracy score for CAC progression was 80%, precision score of 79% and recall score 83%. The score for blood pressure was 74% (accuracy, precision and recall). There were no side-effects in either group.ConclusionsAGE inhibits CAC progression, lowers IL–6, glucose levels and blood pressure in patients at increased risk of cardiovascular events in a European cohort. An algorithm was made and was used to predict with 80% precision which patient will have a significantly reduced CAC progression using AGE. The algorithm could also predict with a 74% precision which patient will have a significant blood pressure lowering effect pressure using AGE.Trial registrationClinical trials NCT03860350, retrospectively registered (1/32019).
Highlights
One of the most serious secondary manifestations of Cardiovascular Disease (CVD) is coronary atherosclerosis
The algorithm could predict with a 74% precision which patient will have a significant blood pressure lowering effect pressure using aged garlic extract (AGE)
A total of 175 patients with a Framingham risk score ≥ 10 were assessed for the study and underwent a cardiac computed tomography (CT) scan
Summary
One of the most serious secondary manifestations of Cardiovascular Disease (CVD) is coronary atherosclerosis. Cardiovascular disease (CVD) kills 17.9 million people every year, accounts for 31% of all global deaths, and is considered to be the leading cause of death worldwide [1]. Hypertension and hyperlipidemia are two of the most important risk factors for CVD [1]. Hypertension affects more than 1 billion (one in four) adults worldwide, and about 40% of all premature deaths (under the age of 70 years) worldwide are caused by CVD [1]. One of the most serious secondary manifestations of hypertension and hyperlipidemia is coronary atherosclerosis, which can lead to myocardial infarction. The progression of CAC is becoming an acceptable prognostic factor for evaluating the effectiveness of interventions instead of end-points such as myocardial infarction and cardiac disease mortality [4]
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