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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorHospital de Clinicas José de San Martín

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Serum cortisol.

    Diagnostic test

    Serum cortisol levels obtained on admission.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Cardiovascular Death

Death caused by heart-related conditions.

Time frame
1 year

Secondary outcomes

1

Myocardial Infarction

The occurrence of a Myocardial Infarction (4th International Definition).

Time frame
1 year
2

Stroke

The occurrence of a cerebrovascular event such as ischemic or hemorrhagic stroke.

Time frame
1 year
3

Revascularization Procedures

Including coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).

Time frame
1 year
4

Hospitalization for Unstable Angina

Admission to the hospital due to chest pain or other symptoms indicative of unstable angina.

Time frame
1 year

Other outcomes

1

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

Time frame
1 week
2

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

Time frame
1 week
3

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

Time frame
1 week

Sponsors and contacts

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Hospital de Clinicas José de San Martín

Lead sponsor

University of Buenos Aires

Collaborator