Cellular Immunity, Neuroendocrine, and Inflammatory Factors for Clinical Prognosis in Acute Coronary Syndrome

NCT06513611 | Recruiting

• 1 other identifier: 20720220200021BA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Stress Hyperglycemia; Cortisol; Hypersecretion; Inflammatory Response; Coagulation

Keywords

acute coronary syndrome; inflammation; cellular immunity

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Death

  Death caused by heart-related conditions.

  1 year

Secondary Outcomes (4)

• Myocardial Infarction

  1 year

• Stroke

  1 year

• Revascularization Procedures

  1 year

• Hospitalization for Unstable Angina

  1 year

Other Outcomes (3)

• Correlation of the leukocyte, neutrophil, lymphocyte, and eosinophil counts with maximum levels of high-sensitivity troponin.

  1 week

• Correlation the leukocyte, neutrophil, lymphocyte, and eosinophil counts with total serum cortisol levels

  1 week

• Correlation the leukocyte, neutrophil, lymphocyte, and eosinophil counts with CRP levels.

  1 week

Interventions

Serum cortisol. DIAGNOSTIC_TEST

Serum cortisol levels obtained on admission.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible patients admitted with a diagnosis of Acute Coronary Syndrome to the Coronary Unit of the Hospital de Clínicas José de San Martín in the Autonomous City of Buenos Aires.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas José de San Martín: lead
• University of Buenos Aires: collaborator

Study Sites (1)

Hospital de Clinicas Jose de San Martin

Buenos Aires, Argentina

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum.

MeSH Terms

Conditions

Acute Coronary Syndrome; Thrombosis; Inflammation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra P Sweiszkowski, MD, MSc.

  Hospital de Clinicas Jose de San Martin

  STUDY DIRECTOR

Central Study Contacts

Diego Costa, MD, MSc.

CONTACT

54 9 11 6198 4472; diegosta@gmail.com

Sandra P Sweiszkowski, MD, MSc.

CONTACT

54 9 11 5053 3633; sandraswies@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc.

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: January 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)