Characteristics of clinical trials evaluating cardiovascular therapies for Coronavirus Disease 2019 Registered on ClinicalTrials.gov: a cross sectional analysis.

Morbidity and mortality associated with COVID-19 has increased exponentially, and patients with cardiovascular (CV) disease are at risk for poor outcomes. Several lines of evidence suggest a potential role for CV therapies in COVID-19 treatment. Characteristics of clinical trials of CV therapies related to COVID-19 registered on ClinicalTrials.gov have not been described. METHODS: ClinicalTrials.gov was queried on August 7, 2020 for COVID-19 related trials. Studies evaluating established CV drugs, other fibrinolytics (defibrotide), and extracorporeal membrane oxygenation were included. Studies evaluating anti-microbial, convalescent plasma, non-colchicine anti-inflammatory, and other therapies were excluded. Trial characteristics were tabulated from study-specific entries. RESULTS: A total of 2,935 studies related to COVID-19 were registered as of August 7, 2020. Of these, 1,645 were interventional studies, and the final analytic cohort consisted of 114 studies evaluating 10 CV therapeutic categories. Antithrombotics (32.5%; n = 37) were most commonly evaluated, followed by pulmonary vasodilators (14.0%; n = 16), renin-angiotensin-aldosterone system-related therapies (12.3%; n = 14), and colchicine (8.8%; n = 10). Trials evaluating multiple CV therapy categories and CV therapies in combination with non-CV therapies encompassed 4.4% (n = 5) and 9.6% (n = 11) of studies, respectively. Most studies were designed for randomized allocation (87.7%; n = 100), enrollment of less than 1000 participants (86.8%; n = 99), single site implementation (55.3%; n = 63), and had a primary outcome of mortality or a composite including mortality (56.1%; n = 64). Most study populations consisted of patients hospitalized with COVID-19 (81.6%; n = 93). At the time of database query, 28.9% (n = 33) of studies were not yet recruiting and the majority were estimated to be completed after December 2020 (67.8%; n = 78). Most lead sponsors were located in North America (43.9%; n = 50) or Europe (36.0%; n = 41). CONCLUSIONS: A minority (7%) of clinical trials related to COVID-19 registered on ClinicalTrials.gov plan to evaluate CV therapies. Of CV therapy studies, most were planned to be single center, enroll less than 1000 inpatients, sponsored by European or North American academic institutions, and estimated to complete after December 2020. Collectively, these findings underscore the need for a network of sites with a platform protocol for rapid evaluation of multiple therapies and generalizability to inform clinical care and health policy for COVID-19 moving forward.

Identifying patients for safe early hospital discharge following st elevation myocardial infarction.

OBJECTIVES: To examine whether the CADILLAC risk score is an effective method of patient stratification for early discharge following ST elevation myocardial infarction (STEMI). BACKGROUND: Patients with STEMI are typically hospitalized to monitor for serious complications such as arrhythmias, heart failure, and reinfarction. Optimal length of stay is unclear. Whether low risk patients can be safely discharged before 72 hr of hospitalization is unclear. METHODS: Patients with STEMI who underwent successful PCI were retrospectively stratified using CADILLAC risk score to low risk (n = 123) and intermediate to high risk (n = 105). The primary outcome was adverse clinical events at day 3 or later. Secondary outcomes were adverse clinical events on day 1 and mortality rates at 30 days and 31 to 365 days. RESULTS: Low risk patients had lower major adverse clinical events at day 3 or later (0 vs. 11.4%, P = 0.0002) and lower total mortality at 1 year (0 vs. 4.8%, P = 0.02) than patients with intermediate to high risk. Low risk patients were also less likely to have a cardiovascular event during the first 24 hr when compared to those with an intermediate to high risk score (3.3% vs. 13.3%, P = 0.006). CONCLUSION: Low risk patients identified using CADILLAC risk score with STEMI treated successfully with primary PCI have a low adverse event rate on the third day or later of hospitalization suggesting that an earlier discharge is safe in properly selected patients. Monitoring in a noncritical care setting following primary PCI for STEMI may be feasible for selected patients. © 2016 Wiley Periodicals, Inc.

Emphysematous pancreatitis with pulmonary embolism: A case report.

Background: Emphysematous pancreatitis is a severe systemic inflammatory process with reports of pulmonary embolism in the setting of acute pancreatitis rarely described. Case presentation: A 61-year-old woman presented with severe abdominal pain of 1 day duration. She was found to have acute interstitial pancreatitis. During her hospitalization, the patient developed worsening abdominal pain associated with increasing oxygen demands, requiring supplemental oxygen through nasal cannula. Workup showed pulmonary embolism in the posterior segmental branch of the left lower lobar artery and development of emphysematous pancreatitis was noted on imaging. The patient was started on intravenous antibiotics and therapeutic anticoagulation; her condition improved and was discharged home. Conclusion: Patients with severe acute pancreatitis may be at risk for pulmonary embolism due to immobilization and other inflammatory mechanisms. Mitigating individualized risk factors and anticoagulation use as prophylaxis should be considered in patients with pancreatitis to prevent embolism. Early detection by clinicians is critical to reduce misdiagnosis and mortality rates.

Current perspectives on location of monitoring and length of stay following PPCI for ST elevation myocardial infarction.

IMPORTANCE: There is marked variability in location of care and hospital length of stay after primary percutaneous coronary intervention for ST elevation myocardial infarction (STEMI). OBSERVATIONS: We performed a literature review on non-critical care monitoring and early discharge following primary percutaneous coronary intervention and describe a framework for implementation in the real world. The medical literature was searched from 1 January 1988 to 31 April 2019 using PubMed and Cochrane Central Register of Controlled Trials. Randomized clinical trials, observational studies and guideline statements were included. Available data suggest that carefully selected low-risk STEMI patients identified using Zwolle or CADILLAC risk stratification scores after primary percutaneous coronary intervention may be considered for discharge after 48 hours of hospital care. There was no increase in major adverse cardiac events, medication non-compliance or hospital readmission with this treatment strategy. There are limited data on non-critical monitoring of uncomplicated STEMI patients; however, given the low adverse events rate, this strategy is likely to be safe in selected patients and may facilitate reduced length of stay and reduce resource utilization. CONCLUSIONS AND RELEVANCE: Available evidence supports the safety of early discharge after 48 hours of care and omission of critical care monitoring in carefully selected patients following primary percutaneous coronary intervention. Early risk stratification and structured discharge planning are imperative. Adoption of this treatment strategy could reduce hospital costs, resource utilization and enhance patient satisfaction without affecting outcomes.