Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT04905160
Eligibility Criteria:
Inclusion Criteria:
Men and women over 18 years of age are included. Eligible subjects must be hospitalized with a primary diagnosis of ADHF or acute MI. The diagnosis of HF is established by the presence of typical symptoms, signs, and objective evidence of pulmonary congestion, elevated BNP or N-terminal pro B-type natriuretic peptide (NT-pro BNP) or impaired cardiac function. Acute MI is diagnosed by presence of chest pain, arm pain, or dyspnea with elevated Troponin and/or EKG changes suggestive of Acute coronary syndrome requiring intervention or optimal medical therapy.
Exclusion Criteria:
1. Study informed consent will be obtained before enrollment in the study for Phase 1 and Phase 2
2. All subjects 18 years or above will be a criteria for inclusion for Phase 1
3. For Phase 2, men and women 50 years or older with positive Covid19 antigen test and one other risk factor as mentioned in the comorbid section of workflow will be enrolled in the intervention arm of the study;
4. For phase 2, subjects should be able to be randomized within 48 hours of Covid19 antigen positive status
5. Patients considered unreliable by the investigator concerning the requirements for follow-up visits
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04905160
Study Brief:
Protocol Section:
NCT04905160