Myocardial Infarction with Nonobstructive Coronary Arteries.

Myocardial infarction with nonobstructive coronary arteries (MINOCA) is an important subtype of myocardial infarction (MI) that occurs in approximately 6-8% of patients with spontaneous MI who are referred for coronary angiography. MINOCA disproportionately affects women, but men are also affected. Pathogenesis is more variable than in MI with obstructive coronary artery disease (MI-CAD). Dominant mechanisms include atherosclerosis, thrombosis, and coronary artery spasm. Management of MINOCA varies based on the underlying mechanism of infarction. Therefore, systematic approaches to diagnosis are recommended. The combination of invasive coronary angiography, multivessel intracoronary imaging, provocative testing for coronary spasm, and cardiac magnetic resonance imaging provides the greatest diagnostic yield. Current clinical practice guidelines for the secondary prevention of MI are based largely on data from patients with MI-CAD. Thus, optimal medications after MINOCA are uncertain. Clinical trials focused on the treatment of patients with MINOCA are urgently needed to define optimal care.

Digitizing clinical trials.

Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and medical devices and other health system interventions. The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions. The concept of a "digital clinical trial" involves leveraging digital technology to improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation, and has the potential to transform clinical trials and to lower their cost. In April 2019, the US National Institutes of Health (NIH) and the National Science Foundation (NSF) held a workshop bringing together experts in clinical trials, digital technology, and digital analytics to discuss strategies to implement the use of digital technologies in clinical trials while considering potential challenges. This position paper builds on this workshop to describe the current state of the art for digital clinical trials including (1) defining and outlining the composition and elements of digital trials; (2) describing recruitment and retention using digital technology; (3) outlining data collection elements including mobile health, wearable technologies, application programming interfaces (APIs), digital transmission of data, and consideration of regulatory oversight and guidance for data security, privacy, and remotely provided informed consent; (4) elucidating digital analytics and data science approaches leveraging artificial intelligence and machine learning algorithms; and (5) setting future priorities and strategies that should be addressed to successfully harness digital methods and the myriad benefits of such technologies for clinical research.

Plasma lipid concentrations in hyperlipidemic patients consuming a high-fat diet supplemented with pyruvate for 6 wk.

We evaluated the effects of a three-carbon compound, pyruvate, on plasma lipid concentrations in hyperlipidemic patients consuming a high-cholesterol (560-620 mg), high-fat (45-47% of energy; 18-20% of energy as saturated fatty acid), anabolic diet (0.11-0.12 MJ/kg body wt) for 6 wk. Forty subjects consumed the diet, randomly supplemented with 36-53 g pyruvate (n = 19) or 21-37 g polyglucose (placebo, Polycose, n = 21) as a portion of carbohydrate energy. Plasma cholesterol and LDL-cholesterol concentrations were unchanged in the placebo group, but decreased by 4% and 5%, respectively, in the pyruvate group (P < 0.05 vs placebo). Plasma HDL-cholesterol, HDL3-cholesterol, and triglyceride concentrations were similar in both groups. Resting heart rate, diastolic blood pressure, and rate-pressure product were unchanged after 6 wk of therapy in the placebo group, but decreased by 9%, 6%, and 12%, respectively with pyruvate supplementation (P < 0.05 vs placebo). We conclude that pyruvate supplementation of a high-fat, high-cholesterol, anabolic diet will decrease plasma cholesterol and LDL-cholesterol concentrations without affecting the HDL-cholesterol concentration.

Pyruvate supplementation of a low-cholesterol, low-fat diet: effects on plasma lipid concentrations and body composition in hyperlipidemic patients.

The effects of the three-carbon compound pyruvate on plasma lipid concentrations and body composition were evaluated in hyperlipidemic patients consuming a low-cholesterol (165-180 mg), low-fat (22-24% of energy; 18-20% of energy as saturated fatty acid) diet (0.091-0.099 MJ.kg body wt-1 x d-1). After consuming the above diet for 4 wk, during which time plasma lipid concentrations decreased, 34 subjects were randomly assigned to receive either 22-44 g pyruvate (n = 17) or 18-35 g polyglucose (placebo, Polycose, n = 17), iso-energetically substituted for a portion of carbohydrate energy for 6 wk. Despite greater weight and fat losses with pyruvate (P < 0.05), plasma concentrations of cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride were not different between the two groups of subjects. We conclude that subsequent to diet-induced reduction in plasma lipid concentrations, pyruvate supplementation of a low-cholesterol, low-fat diet providing 6.7-7.6 MJ/d for 6 wk has no effect on plasma lipid concentrations but enhances body weight and fat losses.

Abdominal aortic aneurysms and thoracic aortic atheromas.

BACKGROUND: Abdominal aortic aneurysm (AAA) is associated with atherosclerosis elsewhere. Thoracic aortic atheromas (ATHs) seen on transesophageal echocardiography (TEE) are an important cause of stroke and peripheral embolization. The purposes of this study were to determine whether an association exists between AAA and ATHs and to assess the importance of screening patients with ATHs for AAA. METHODS: For the retrospective analysis, 109 patients with AAA and 109 matched controls were compared for the prevalence of ATHs on TEE and for historical variables. For the prospective analysis, screening for AAA on ultrasonography was performed in 364 patients at the time of TEE. RESULTS: Results of the retrospective analysis showed that ATHs were present in 52% of patients with AAA and in 25% of controls (odds ratio [OR] = 3.3; P =.00003). There was a significantly higher prevalence of hypertension, myocardial infarction, heart failure, smoking, and carotid or peripheral arterial disease in patients with AAA. However, only ATHs were independently associated with AAA on multivariate analysis (P =.001). Results of the prospective analysis showed that screening at the time of TEE in 364 patients revealed AAA in 13.9% of those with ATHs and in 1.4% of those without ATHs (P <.0001; OR = 11.4). CONCLUSIONS: (1) There is a strong, highly significant association between abdominal aneurysm and thoracic atheromas. (2) Patients with AAA may be at high risk for stroke because of the concomitance of thoracic aortic atheromas. (3) The high prevalence of abdominal aneurysm in patients with thoracic atheromas suggests that screening for abdominal aneurysm should be carried out in all patients with thoracic atheromas identified by TEE.

Preliminary results of skin cancer screening in West Virginia.

Although skin cancer screening is theoretically of value, its effectiveness has not been firmly established because few studies have systematically followed persons with a positive screen to obtain pathologically confirmed diagnoses. From the 799 persons screened at Charleston Area Medical Center in 1988 and 1989, 153 screenees with suspected skin cancer, dysplastic nevi, and congenital nevi were followed to determine their final diagnosis. Follow-up was done by letter and telephone calls to both the individuals who screened positive and their treating physicians. Eighty-four (54 percent) then sought medical attention as a result of letters and calls. Thirty-one basal cell carcinomas, three squamous cell carcinomas, three dysplastic nevi, two melanomas, and one congenital nevus were pathologically confirmed. The predictive value positive of the screenings was 32 percent to 60 percent for non-melanoma skin cancer, 9 percent to 25 percent for dysplastic nevi, and 15 percent for melanoma. This study suggests that post-screening follow-up of those with suspected premalignant and malignant skin lesions is feasible and should be encouraged so that more definitive evaluation and treatment can potentially be performed and skin cancer screenings more accurately assessed.