Actively Recruiting
Relationship Between Cellular Immunity Components and Neuroendocrine and Inflammatory Factors for Clinical Prognosis in Acute Coronary Syndrome
Led by Hospital de Clinicas José de San Martín · Updated on 2024-07-22
150
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
H
Hospital de Clinicas José de San Martín
Lead Sponsor
U
University of Buenos Aires
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying acute coronary syndrome (ACS), a condition caused by reduced blood flow to the heart, leading to heart tissue damage. This research focuses on understanding how stress and inflammation responses, shown by increased cortisol and C-reactive protein (CRP) levels, relate to changes in immune cells in the blood. The study aims to see how these factors predict clinical outcomes during hospital stays and after discharge in ACS patients. This is a prospective, observational study involving patients admitted with ACS to a coronary care unit over two years. Blood samples will be collected at admission to measure cortisol and CRP levels, along with counts of immune cells like leukocytes, neutrophils, lymphocytes, and eosinophils. Patients will receive usual medical care, and their clinical progress will be monitored through laboratory markers and medical records. After hospital discharge, participants will be followed up by telephone for six months. Participants will undergo baseline physical exams and electrocardiograms at admission, with regular blood tests to track heart damage markers and immune cell counts. Researchers will analyze these data to find links between immune responses, stress, inflammation, and patient outcomes. The primary outcome is cardiovascular death within one year, with secondary outcomes including heart attacks, strokes, revascularization procedures, and hospitalizations for unstable angina. The total study period includes two years of enrollment and six months of follow-up for each patient.
CONDITIONS
Brief Title
Cellular Immunity, Neuroendocrine, and Inflammatory Factors for Clinical Prognosis in Acute Coronary Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are over 21 years of age and admitted to the Coronary Unit with a diagnosis of Acute Coronary Syndrome (ACS).
- Agree to participate in the study through informed consent.
You will not qualify if you...
- Have a chronic neoplastic or inflammatory disease.
- Have an allergic disease, parasitic disease, asthma, or hypereosinophilic syndrome.
- Have severe associated valvular heart disease.
- Had an acute myocardial infarction in the previous month.
- Are on chronic corticosteroid treatment.
- Have creatinine clearance below 30% by MDRD.
- Have severe liver failure.
- Are pregnant.
- Have a known disease limiting life expectancy to 6 months.
- Refuse to participate or cannot understand the study due to clinical condition.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital admission period
Participants undergo blood sampling and clinical evaluation at admission to measure immune, inflammatory, and stress markers associated with acute coronary syndrome.
1 visit (in-person) at admission
Duration - 6 months
Participants are followed up by telephone for 6 months after discharge to monitor clinical events and outcomes related to acute coronary syndrome.
Telephone follow-up contacts during 6 months post-discharge
Trial Site Locations
Total: 1 location
1
Hospital de Clinicas Jose de San Martin
Buenos Aires, Argentina
Actively Recruiting
Research Team
D
Diego Costa, MD, MSc.
S
Sandra P Sweiszkowski, MD, MSc.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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