Clinical trial NCT02737982: Sex and Gender Differences in Ischemic Heart Disease - Endocrine Vascular Disease Approach
Official title: Sex and Gender Differences in Ischemic Heart Disease: From Bench to Bedside EVA (Endocrine Vascular Disease Approach)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Ischemia
Keywords: coronary heart disease
gender
platelet
microvascular dysfunction
sexual hormones
cardiac magnetic resonance
percutaneous coronary interventions
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Universities and Research, Italy
First posted: 2016-04-14
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women who referred with a suspected IHD to the cath-lab for undergoing percutaneous coronary intervention

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade
timeFrame: baseline; within 1h from PCI
Secondary outcomes:
measure: Sexual hormones levels in patients with IHD undergoing PCI
timeFrame: baseline
measure: Platelet activation markers including Thromboxane, soluble cluster designation 40 (CD40) Ligand and soluble P-selectin in patients with IHD undergoing PCI
timeFrame: baseline; within 1h from PCI; 12 months
measure: Clinical outcomes including cardiovascular mortality, re-hospitalization and restenosis
timeFrame: 12 months
measure: Microvascular dysfunction assessed by cardiac magnetic resonance
timeFrame: 7 days from percutaneous coronary intervention
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Umberto I , Sapienza University of Rome
Study officials:
affiliation: Experimental Medicine Department, Sapienza University of Rome
name: Valeria Raparelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.