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

Myocardial Ischemia Clinical Trial

— EVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737982
• Other study ID #: RBSI14HNVT
• Status: Completed
• Start date: April 2016
• Est. completion date: September 2020

Study information

• Verified date: November 2020
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: September 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia
• Vascular Diseases

Intervention

Procedure:
• percutaneous coronary intervention
coronary angiography with or without stent implantation, measurement of indexes of epicardial and microvascular reperfusion

Locations

Country	Name	City	State
Italy	Policlinico Umberto I , Sapienza University of Rome	Rome

Sponsors (2)

Lead Sponsor	Collaborator
University of Roma La Sapienza	Ministry of Education, Universities and Research, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade	angiographic assessment of coronary flow	baseline; within 1h from PCI
Secondary	Sexual hormones levels in patients with IHD undergoing PCI	Evaluation and impact of sexual hormones levels in gender-related differences during myocardial reperfusion	baseline
Secondary	Platelet activation markers including Thromboxane, soluble cluster designation 40 (CD40) Ligand and soluble P-selectin in patients with IHD undergoing PCI	Evaluation of Sex and gender differences in platelet function	baseline; within 1h from PCI; 12 months
Secondary	Clinical outcomes including cardiovascular mortality, re-hospitalization and restenosis		12 months
Secondary	Microvascular dysfunction assessed by cardiac magnetic resonance	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.	7 days from percutaneous coronary intervention