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| Name | Class |
|---|---|
| Ministry of Education, Universities and Research, Italy | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IHD Men | Men with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions |
| |
| IHD Women | Women with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous coronary intervention | Procedure | coronary angiography with or without stent implantation, measurement of indexes of epicardial and microvascular reperfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade | angiographic assessment of coronary flow | baseline; within 1h from PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual hormones levels in patients with IHD undergoing PCI | Evaluation and impact of sexual hormones levels in gender-related differences during myocardial reperfusion | baseline |
| Platelet activation markers including Thromboxane, soluble cluster designation 40 (CD40) Ligand and soluble P-selectin in patients with IHD undergoing PCI |
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Inclusion Criteria:
Exclusion Criteria:
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Men and women who referred with a suspected IHD to the cath-lab for undergoing percutaneous coronary intervention
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| Name | Affiliation | Role |
|---|---|---|
| Valeria Raparelli, MD | Experimental Medicine Department, Sapienza University of Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Umberto I , Sapienza University of Rome | Rome | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37004526 | Derived | Raparelli V, Romiti GF, Di Teodoro G, Seccia R, Tanzilli G, Viceconte N, Marrapodi R, Flego D, Corica B, Cangemi R, Pilote L, Basili S, Proietti M, Palagi L, Stefanini L; EVA Investigators. A machine-learning based bio-psycho-social model for the prediction of non-obstructive and obstructive coronary artery disease. Clin Res Cardiol. 2023 Sep;112(9):1263-1277. doi: 10.1007/s00392-023-02193-5. Epub 2023 Apr 1. | |
| 30858826 |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003327 | Coronary Disease |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D012725 | Sexual Behavior |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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plasma, serum, urine
Evaluation of Sex and gender differences in platelet function |
| baseline; within 1h from PCI; 12 months |
| Clinical outcomes including cardiovascular mortality, re-hospitalization and restenosis | 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. | 7 days from percutaneous coronary intervention |
| Derived |
| Raparelli V, Proietti M, Romiti GF, Lenzi A, Basili S; EVA Collaborative Group. The Sex-Specific Detrimental Effect of Diabetes and Gender-Related Factors on Pre-admission Medication Adherence Among Patients Hospitalized for Ischemic Heart Disease: Insights From EVA Study. Front Endocrinol (Lausanne). 2019 Feb 25;10:107. doi: 10.3389/fendo.2019.00107. eCollection 2019. |
| 30511337 | Derived | Raparelli V, Proietti M, Lenzi A, Basili S; EVA Collaborators. Sex and Gender Differences in Ischemic Heart Disease: Endocrine Vascular Disease Approach (EVA) Study Design. J Cardiovasc Transl Res. 2020 Feb;13(1):14-25. doi: 10.1007/s12265-018-9846-5. Epub 2018 Dec 3. |
| D001519 |
| Behavior |
| D019060 | Minimally Invasive Surgical Procedures |