NCT06513611 Cellular Immunity, Neuroendocrine, and Inflammatory Factors for Clinical Prognosis in Acute Coronary Syndrome
| NCT ID | NCT06513611 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital de Clinicas José de San Martín |
| Condition | Acute Coronary Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2024-01-01 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In acute coronary syndrome (ACS), there is an increase in cortisol levels, as an expression of the stress response, and C-reactive protein, as an expression of the inflammatory response, which are in turn associated with changes in the components of cellular immunity, and ultimately are predictors of clinical events. The objective of this study is to demonstrate that, within the frame of reference of ACS, beyond the thrombotic phenomenon that leads to ischemia and myocardial necrosis, there is an activation of an inflammatory and stress response, evidenced by an elevation of CRP and cortisol, respectively, and sequentially modifications in the components of cellular immunity in peripheral blood that convey prognostic value during hospitalization and after discharge. A prospective, observational, analytical, unicentric study of consecutive patients with ACS, with telephone follow-up to 6 months, will be carried out. For 2 years, all eligible patients admitted with a diagnosis of ACS to the Coronary Care Unit of the Hospital de Clínicas José de San Martín in Buenos Aires will be registered consecutively.
Eligibility Criteria
Inclusion Criteria: * Are over 21 years of age and admitted to the Coronary Unit of the Hospital de Clínicas with a diagnosis of Acute Coronary Syndrome (ACS). * Agree to participate in the study through informed consent. Exclusion Criteria: * Concomitant diagnosis of chronic neoplastic or inflammatory disease. * Diagnosis of allergic disease, parasitic disease, asthma, or hypereosinophilic syndrome. * Severe associated valvular disease. * Acute myocardial infarction (AMI) in the previous month. * Chronic corticosteroid treatment. * Creatinine clearance \<30% by MDRD (Modification of Diet in Renal Disease). * Severe hepatic insufficiency. * Pregnant women. * Known disease that limits their life expectancy to 6 months. * Refuse to participate in the study either by their own will or unable to understand its characteristics due to their clinical condition.
Contact & Investigator
Sandra P Sweiszkowski, MD, MSc.
STUDY DIRECTOR
Hospital de Clinicas Jose de San Martin
Frequently Asked Questions
Who can join the NCT06513611 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06513611 currently recruiting?
Yes, NCT06513611 is actively recruiting participants. Contact the research team at diegosta@gmail.com for enrollment information.
Where is the NCT06513611 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina.
Who is sponsoring the NCT06513611 clinical trial?
NCT06513611 is sponsored by Hospital de Clinicas José de San Martín. The principal investigator is Sandra P Sweiszkowski, MD, MSc. at Hospital de Clinicas Jose de San Martin. The trial plans to enroll 150 participants.