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Clinical Trials/NCT02737982
NCT02737982
Completed
Not Applicable

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

University of Roma La Sapienza1 site in 1 country509 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Ischemia
Sponsor
University of Roma La Sapienza
Enrollment
509
Locations
1
Primary Endpoint
Assessment of corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
September 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Roma La Sapienza
Responsible Party
Principal Investigator
Principal Investigator

Valeria Raparelli

University Reseacher

University of Roma La Sapienza

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Assessment of corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade

Time Frame: baseline; within 1h from PCI

angiographic assessment of coronary flow

Secondary Outcomes

  • Clinical outcomes including cardiovascular mortality, re-hospitalization and restenosis(12 months)
  • Sexual hormones levels in patients with IHD undergoing PCI(baseline)
  • 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)
  • Microvascular dysfunction assessed by cardiac magnetic resonance(7 days from percutaneous coronary intervention)

Study Sites (1)

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