Sex and Gender Differences in Ischemic Heart Disease - Endocrine Vascular Disease Approach
Condition: Myocardial Ischemia
MeSH terms: Heart Diseases; Vascular Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Observational [Patient Registry]

Summary: 
      The application of sex-gender medicine is strongly recommended by World Health Organization
      and other international organization. In fact, it is emerging that, although men and women
      are affected to the same cardiovascular diseases (CVD), however they have different risk
      factors, disease progression and response to pharmacological and not-pharmacological
      treatments. Consequentially, the identification of biomarkers and therapeutic approaches
      taking into account sex gender differences (SGD) is relevant to develop a really
      evidence-based medicine.

      With the aim of translate in clinical setting the more recently available basic research
      evidences on estrogens and androgens balance involvement in modulation of
      ischemia-reperfusion myocardial damage, the investigators planned to conduct a research study
      on patients, affected by suspected or known ischemic heart disease (IHD) undergoing
      angiography and/or percutaneous coronary interventions (PCI), aged more than 18 years of both
      sex in ratio 1:1. Thus, in this setting, the goals of this proposal are:

        1. To assess the sex-gender difference in entity of microvascular reperfusion damage in
           patients with IHD undergoing urgent or elective PCI;

        2. To evaluate estrogen/androgen-dependent and -independent effects in gender-related
           differences on myocardial ischemia reperfusion damage occurring during PCI;

        3. To investigate the differences in terms of platelet biology between men and women
           affected by IHD undergoing urgent or elective PCI, matched for age and clinical
           cardiovascular and metabolic characteristics;

        4. To verify sex-driven interplay between response to PCI procedure, platelet function, sex
           hormones and entity of reperfusion and myocardial damage, as well as, the impact on
           clinical outcomes during a 1-year follow up.

      This research study wants to explore and consequently elucidate biological mechanisms
      responsible for sex-based differences in vivo human models of ischemia reperfusion myocardial
      damage. Moreover, the investigators expected to clarify the impact of biological variables
      evaluated on clinical outcomes after reperfusion therapeutic intervention.
    


Intervention name(s): percutaneous coronary intervention
Intervention type(s): Procedure
Intervention description(s): coronary angiography with or without stent implantation, measurement of indexes of epicardial and microvascular reperfusion
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Men and women who referred with a suspected IHD to the cath-lab for undergoing percutaneous
        coronary intervention
      
Biospecimen description: 
      plasma, serum, urine
    
Keywords: coronary heart disease; gender; platelet; microvascular dysfunction; sexual hormones; cardiac magnetic resonance; percutaneous coronary interventions