NCT02737982

Sex and Gender Differences in Ischemic Heart Disease - Endocrine Vascular Disease Approach

Sex and Gender Differences in Ischemic Heart Disease: From Bench to Bedside EVA (Endocrine Vascular Disease Approach)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 509 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Ischemia

Interventions

Type	Name	Description
PROCEDURE	percutaneous coronary intervention	coronary angiography with or without stent implantation, measurement of indexes of epicardial and microvascular reperfusion

Timeline

• Start date: 2016-04-01
• Primary completion: 2020-03-01
• Completion: 2020-09-01
• First posted: 2016-04-14
• Last updated: 2020-11-10

Locations

1 site across 1 country: Italy