An observational study in Myocardial Ischemia, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-11-10.
Sponsored by University of Roma La Sapienza · Observational
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:
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.
3,640 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 509 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men and women who referred with a suspected IHD to the cath-lab for undergoing percutaneous coronary intervention
Exclusion Criteria:
Men with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions
Procedure: percutaneous coronary intervention
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
Assessment of corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade
angiographic assessment of coronary flow
Time frame: baseline; within 1h from PCI
Sexual hormones levels in patients with IHD undergoing PCI
Evaluation and impact of sexual hormones levels in gender-related differences during myocardial reperfusion
Time frame: baseline
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
Time frame: baseline; within 1h from PCI; 12 months
Clinical outcomes including cardiovascular mortality, re-hospitalization and restenosis
Time frame: 12 months
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.
Time frame: 7 days from percutaneous coronary intervention
Plan to share: Undecided
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza