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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02737982
Acronym
EVA
Enrollment
509
Registered
2016-04-14
Start date
2016-04-30
Completion date
2020-09-30
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

Keywords

coronary heart disease, gender, platelet, microvascular dysfunction, sexual hormones, cardiac magnetic resonance, percutaneous coronary interventions

Brief 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.

Interventions

PROCEDUREpercutaneous coronary intervention

coronary angiography with or without stent implantation, measurement of indexes of epicardial and microvascular reperfusion

Sponsors

Ministry of Education, Universities and Research, Italy
CollaboratorOTHER
University of Roma La Sapienza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush gradebaseline; within 1h from PCIangiographic assessment of coronary flow

Secondary

MeasureTime frameDescription
Sexual hormones levels in patients with IHD undergoing PCIbaselineEvaluation and impact of sexual hormones levels in gender-related differences during myocardial reperfusion
Platelet activation markers including Thromboxane, soluble cluster designation 40 (CD40) Ligand and soluble P-selectin in patients with IHD undergoing PCIbaseline; within 1h from PCI; 12 monthsEvaluation of Sex and gender differences in platelet function
Clinical outcomes including cardiovascular mortality, re-hospitalization and restenosis12 months
Microvascular dysfunction assessed by cardiac magnetic resonance7 days from percutaneous coronary interventionAmong the EVA registry, we plan to perform a pilot study including: patients with stable angina with mono-vessel obstructive coronary artery disease (CAD) undergoing PCI; patients with stable angina undergoing angiography that documented no obstructive coronary disease (with a stenosis \<50%) with a impairment of microvascular dysfunction defined during angiography by a myocardial blush grade \<2 or coronary flow reserve \<2 after stress stimulus.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026