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临床试验/NCT02737982
NCT02737982已完成不适用

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

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 509 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
509
试验地点
1
主要终点
Assessment of corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: baseline; within 1h from PCI

angiographic assessment of coronary flow

次要结局

  • 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)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Valeria Raparelli

University Reseacher

University of Roma La Sapienza

研究点 (1)

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