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NCT Number: NCT02737982

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico Umberto I , Sapienza University of Rome

Rome, 00161, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention

Procedure

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

Primary outcomes

  1. 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

  1. Sexual hormones levels in patients with IHD undergoing PCI

    Time frame: baseline

    Evaluation and impact of sexual hormones levels in gender-related differences during myocardial reperfusion

  2. Platelet activation markers including Thromboxane, soluble cluster designation 40 (CD40) Ligand and soluble P-selectin in patients with IHD undergoing PCI

    Time frame: baseline; within 1h from PCI; 12 months

    Evaluation of Sex and gender differences in platelet function

  3. Clinical outcomes including cardiovascular mortality, re-hospitalization and restenosis

    Time frame: 12 months

  4. Microvascular dysfunction assessed by cardiac magnetic resonance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Collaborators

  • Ministry of Education, Universities and Research, Italy

Registry information

Official study title

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

Acronym: EVA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2016
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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