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

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Completed

CT.gov ID

NCT02737982

Collaborator

Ministry of Education, Universities and Research, Italy (Other)

509

Enrollment

Location

Actual Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

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:

To assess the sex-gender difference in entity of microvascular reperfusion damage in patients with IHD undergoing urgent or elective PCI;
To evaluate estrogen/androgen-dependent and -independent effects in gender-related differences on myocardial ischemia reperfusion damage occurring during PCI;
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;
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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Ischemia	Procedure: percutaneous coronary intervention

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

509 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
IHD Men Men with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions	Procedure: percutaneous coronary intervention coronary angiography with or without stent implantation, measurement of indexes of epicardial and microvascular reperfusion
IHD Women Women with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions	Procedure: percutaneous coronary intervention coronary angiography with or without stent implantation, measurement of indexes of epicardial and microvascular reperfusion

Arm

Intervention/Treatment

IHD Men

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

Procedure: percutaneous coronary intervention

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

IHD Women

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

Procedure: percutaneous coronary intervention

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

Outcome Measures

Primary Outcome Measures

Assessment of corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade [baseline; within 1h from PCI]
angiographic assessment of coronary flow

Secondary Outcome Measures

Sexual hormones levels in patients with IHD undergoing PCI [baseline]
Evaluation 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 PCI [baseline; within 1h from PCI; 12 months]
Evaluation of Sex and gender differences in platelet function
Clinical outcomes including cardiovascular mortality, re-hospitalization and restenosis [12 months]
Microvascular dysfunction assessed by cardiac magnetic resonance [7 days from percutaneous coronary intervention]
Among 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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