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

University of Roma La Sapienza

Status: Completed

Conditions: Myocardial Ischemia

Treatments: Procedure: percutaneous coronary intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02737982

RBSI14HNVT

Details and patient eligibility

About

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.

Enrollment: 509 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with ischemic heart disease (acute or chronic) undergoing percutaneous coronary intervention (urgent or elective)
• written informed consent
• both sex
• aged more than 18 years

Exclusion criteria

• patients with expectancy of life less than 12 months
• active cancer
• pregnancy

Trial design

509 participants in 2 patient groups

IHD Men

Description:

Men with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions

Treatment:

Procedure: percutaneous coronary intervention

IHD Women

Description:

Women with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions

Treatment:

Procedure: percutaneous coronary intervention