Cardiology

Number of Participants With Hospitalization or Death [ Time Frame: Up to 28 days ]
Number of Participants With Mortality [ Time Frame: Up to 28 days ]
Time to mortality [ Time Frame: Up to 28 days ]
Time to mortality was the number of days between drug receipt and death.

Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death [ Time Frame: Up to 28 days ]
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7. [ Time Frame: Day 7 ]
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.

Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14. [ Time Frame: Day 14 ]
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.

Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28. [ Time Frame: Day 28 ]
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.

Quality of Life (QOL) as measured by the PROMIS-29 – Physical Function [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function.

Quality of Life (QOL) as measured by the PROMIS-29 – Fatigue [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue.

Quality of Life (QOL) as measured by the PROMIS-29 – Pain [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for pain.

Quality of Life (QOL) as measured by the PROMIS-29 – Depression [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domain with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression.

Quality of Life (QOL) as measured by the PROMIS-29 – Anxiety [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.

Quality of Life (QOL) as measured by the PROMIS-29 – Social [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities.

Quality of Life (QOL) as measured by the PROMIS-29 – Sleep [ Time Frame: Day 7, 14, 28, 90, and 120 ]
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep.

Time Unwell in Days as Measured by the Symptom and Clinical Event Scale [ Time Frame: Up to 14 days ]
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.

Mean Days Benefit as Measured by the Symptom and Clinical Event Scale [ Time Frame: Up to 14 days ]
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Experimental: AF and EKG Interpretation Project ECHO
All recruited participants participate in the AF and EKG Interpretation Project ECHO educational intervention.
Other: AF and EKG Interpretation Project ECHO
The AF and EKG Interpretation Project ECHO program is delivered via Zoom videoconferencing technology and includes 12, 1-hour long sessions that involve education on best practice management of AF for primary care providers. Each session includes an EKG challenge, case presentation by a participant, didactic presentation, and time for open Q&A. Supplementary materials are made available to all participants.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Experimental: Moderate potassium/low sodium
Subjects will consume a diet moderation in potassium and low in sodium.
Dietary Supplement: Placebo
Subjects will receive a placebo capsule on the moderate potassium/low sodium diet and the moderate potassium/high sodium diet

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Experimental: Green Wellness Program: Plants-2-Plate
The Green Wellness Program:Plants-2-Plate is an established program focusing on whole food plant-based predominant eating pattern in academic primary care setting.The dietary approach includes vegetables, fruits, legumes, whole grains, seeds, nuts in small portion, elimination of all or most of animal foods, and reduction of processed foods. Participants will eat ad libitum. In addition, they will receive support to manage stress, improve quality of sleep, and increase physical activity during the SMA.
Other: Green Wellness Program: Plants-2-Plate
A 6-month, intensive interprofessional program focused on a WFPB predominant eating pattern
Other Name: Whole food, plant-based program

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

This Study will collect leftover Specimens that are taken during standard medical care procedures (for example, tissues, whole teeth, blood, saliva, urine, fluids, and cells). Samples will first be processed for clinical purposes, and any discarded portions of the Specimen(s) will be provided to the Sponsor for the Study purposes.
Non-Surplus Specimens Types to be Collected for Study:
Blood Tooth Bone marrow aspirate Aqueous humor Urine Perineal specimens Rectal specimens Urethral specimens Nasal/Nasopharyngeal and throat specimens Cheek (buccal) specimens Saliva (Sputum) Oral rinse Stool samples Vaginal and cervical specimens Endometrial (uterus) samples Vaginal lavage (wash)

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Experimental: TUS Therapy
These subjects will undergo treatments with the Vibrato Sleeve TUS device.
Device: VibratoSleeve Therapeutic Ultrasound Device
The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Heart failure is one of the leading causes of death, hospitalization and poor quality of life among Veterans. For many Veterans despite receiving maximal medical therapy for heart failure with reduced ejection fraction (HFrEF), their cardiac function and functional capacity markedly decreases and they develop delays and blocks in their intrinsic conduction system (i.e. left bundle branch block). These patients then meet criteria for cardiac resynchronization therapy (CRT), which has been shown to improve cardiac function. However, up to 40% of patients who undergo CRT do not experience the expected improvement in cardiac function or clinical improvement, and this is termed “non-response”.
A critical limitation of traditional CRT is that the leads do not directly utilize the heart’s intrinsic conduction tissue, called the His-Purkinje system. An extensive web of conduction tissue capable of transmitting the electrical signals all over the ventricles within milliseconds, the His-Purkinje system conducts electrical stimuli much faster than conduction through a usual myocardial cell. The left bundle branch is a component of the His-Purkinje system. As such, electrophysiologic therapies that directly activate the left bundle branch area (LBBAP) have emerged as possible solutions to the problem of non-response to CRT. Although data suggests that in patients with complete LBBB, LBBAP can better optimize electrical synchrony and improve cardiac function compared to traditional bi-ventricular CRT, the efficacy has not been studied in CRT non-responders.
Currently, the most frequently used technique for assessment of the left ventricle is echocardiography because it is widely available. However, several studies have demonstrated that cardiac MRI (CMR) is superior to echocardiography in measuring left ventricle ejection fraction, particularly in terms of interstudy reproducibility. Recent studies have also demonstrated CMR imaging to be safe even in patients with non-MRI-conditional pacemakers and defibrillators. Studies have also observed that patients undergoing MRI with non-MRI-conditional pacemakers or ICDs neither experienced device/lead failure nor were they at increased risk by undergoing MRI. Despite established safety of CMR in patients with cardiac devices, it is not being routinely performed because there are concerns that the devices will cause field inhomogeneity resulting in magnetic susceptibility artifacts and non-diagnostic image quality. However, these concerns are overcome by utilizing contemporary imaging protocols with gradient echo sequences as opposed to standard steady-state free precession. By using these new protocols for CMR in this study, the investigators aim to establish the feasibility of CMR to prospectively assess cardiac function at baseline and during follow-up in patients with cardiac devices (i.e. that the image quality in subjects with implantable devices is adequate and not undermined by image artifact).

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

The goal of this study is to objectively test one’s sense of smell, called olfaction, in participants with Subjective Cognitive Concerns (SCC), Mild Cognitive Impairment, Mild Behavioral Impairment (MBI), and age-matched controls. The main question it aims to answer is whether the AROMHA Brain Health Test could serve as a predictive biomarker of neurodegenerative disorders. This understanding will aid in the development of a noninvasive, cost-effective diagnostic tool that reliably and specifically distinguishes disease and normal aging populations.
Participants will take the approximately 45-minute AROMHA Brain Health Smell Test where they will peel and sniff labels on the physical smell cards and answer questions on the web-based app relating to what they smelled. Participants will undergo tests for odor intensity, odor identification, odor discrimination, and episodic olfactory memory, but will not be provided the results of these tests.

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.