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

NCT ID: NCT02737982

Last Updated: 2020-11-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 509 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-09-30

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.

Conditions

Myocardial Ischemia

Keywords

coronary heart disease; gender; platelet; microvascular dysfunction; sexual hormones; cardiac magnetic resonance; percutaneous coronary interventions

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IHD Men

Men with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions

percutaneous coronary intervention

Intervention Type: PROCEDURE

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

IHD Women

Women with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions

percutaneous coronary intervention

Intervention Type: PROCEDURE

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

Interventions

percutaneous coronary intervention

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Education, Universities and Research, Italy

OTHER

Sponsor Role: collaborator

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Valeria Raparelli

University Reseacher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valeria Raparelli, MD

Role: PRINCIPAL_INVESTIGATOR

Experimental Medicine Department, Sapienza University of Rome

Locations

Policlinico Umberto I , Sapienza University of Rome

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 37004526 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30858826 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30511337 (View on PubMed)

Other Identifiers

RBSI14HNVT

Identifier Type: -

Identifier Source: org_study_id