Inclusion of Under-Represented Racial and Ethnic Groups in Cardiovascular Clinical Trials.

INTRODUCTION: Non-White racial and ethnic groups have been traditionally under-represented for decades in the field of cardiology, specifically in cardiovascular research studies. This underrepresentation has occurred despite the fact that these racial and ethnic groups have been shown to be at increased risk of cardiovascular disease (CVD). METHODS: To assess the trend of representation in mainstream landmark cardiovascular trials, we performed a review of major cardiovascular trials published between 1986 and 2019. Mainstream landmark trials were selected as classified by established cardiology standards. The reported numbers of racial and ethnic participants were assessed within these categorised cardiovascular trials over a continuous time period. RESULTS: A total of 1,138,683 patients were assessed from 153 randomised clinical trials. Of these trials, only 56% (n=86) reported information about race. Of note, 99% (n=152) of these trials reported gender. About three-quarters of the trials (77%) were undertaken at least partly in the United States (US). Our results show that the percentage of non-White participants in clinical trials was not significantly different over time (p=0.85), suggesting no significant improvement in non-White racial/ethnic representation. Further analysis of only the US inclusive trials (n=20) also showed no significant improvement in representation (p=0.38). CONCLUSION: Only about half of all major cardiovascular landmark trials reported any racial or ethnic information, despite more recent calls over the last 5-10 years for diversity and representation in cardiovascular research studies. Additionally, no significant improvement in inclusion of traditionally under-represented racial and ethnic groups (UREGs) in these trials has occurred over time. Our analysis shows that there is still major work to be done to foster better representation and evaluation of the UREG population in cardiovascular trials.

Presence of Permanent Pacemakers: Implications for Elderly Patients Presenting with Traumatic Injuries.

Background: The presence of permanent pacemakers (PPM) is common among the elderly population. Trauma literature has shown that the inability to augment cardiac output by at least 30% after injury portends a higher mortality. The presence of a PPM may be a surrogate marker to identify patients who are unable to increase cardiac output. We aimed to evaluate the association between the presence of PPM and clinical outcomes in elderly patients presenting with traumatic injuries. Methods: A total of 4505 patients aged ≥65 years admitted with acute trauma from 2009 to 2019 at our Level I Trauma center were evaluated and stratified into two groups using propensity matching on age, sex, injury severity score (ISS), and year of admission based on the presence of PPM. Logistic regression was performed to analyze the impact of the presence of PPM on mortality, surgical intensive care unit (SICU) admission, operative intervention, and length of stay. Prevalence of cardiovascular comorbidities was compared using χ2 analysis. Results: Data from 208 patients with PPM and 208 propensity-matched controls were evaluated. Charlson Comorbidity Index, mechanism of injury, intensive care unit admission, and rate of operative intervention were comparable in the two groups. PPM patients had more coronary artery disease (p=0.04), heart failure with reduced ejection fraction (p=0.003), atrial fibrillation (AF, p<0.0001), and antithrombotic use (p<0.0001). We found no association between mortality amongst the groups after controlling for influencing variables (OR=2.1 (0.97 to 4.74), p=0.061). Patient characteristics associated with survival included female sex (p=0.009), lower ISS (p<0.0001), lower revised trauma score (p<0.0001), and lower SICU admission (p=0.001). Conclusion: Our study shows no association between mortality among patients with PPM admitted for treatment of trauma. Presence of a PPM may be an indicator of cardiovascular disease, but this does not translate into increased risk in the modern era of trauma management in our patient population. Level of evidence: Level III.

Pheochromocytoma-Induced Cardiomyopathy Mimicking Acute Coronary Syndrome.

Pheochromocytoma is a rare catecholamine-secreting tumor with a prevalence of 0.1% to 0.6% in hypertensive patients. The classic triad of symptoms is headache, palpitations, and diaphoresis, but clinical presentation varies greatly. Pheochromocytoma can also mimic acute coronary syndrome and heart failure. With surgical resection, appropriate preoperative medical therapy, and 10% malignancy rate, prognosis is usually good. In the present case, a patient presented to the emergency department with symptoms suggesting a non-ST-segment elevation myocardial infarction and was transferred to a tertiary medical center for a cardiac catheterization. No coronary artery disease was found. However, cardiomyopathy developed, which made pheochromocytoma difficult to diagnose at first glance.