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

NCT02737982 | Completed DMC

• 1 other identifier: RBSI14HNVT
• Study Type: observational
• Target: 509
• Locations: 1 country
• Sites: 1

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. 1.To assess the sex-gender difference in entity of microvascular reperfusion damage in patients with IHD undergoing urgent or elective PCI;
2. 2.To evaluate estrogen/androgen-dependent and -independent effects in gender-related differences on myocardial ischemia reperfusion damage occurring during PCI;
3. 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. 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.

Conditions

Myocardial Ischemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  angiographic assessment of coronary flow

  baseline; within 1h from PCI

Secondary Outcomes (4)

• 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

• Clinical outcomes including cardiovascular mortality, re-hospitalization and restenosis

  12 months

• Microvascular dysfunction assessed by cardiac magnetic resonance

  7 days from percutaneous coronary intervention

Study Arms (2)

IHD Men

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

Procedure: percutaneous coronary intervention

IHD Women

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

Procedure: percutaneous coronary intervention

Interventions

percutaneous coronary intervention PROCEDURE

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

IHD Men; IHD Women

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men and women who referred with a suspected IHD to the cath-lab for undergoing percutaneous coronary intervention

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Ministry of Education, Universities and Research, Italy: collaborator

Study Sites (1)

Policlinico Umberto I , Sapienza University of Rome

Rome, 00161, Italy

Location

Related Publications (3)

• 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.

  PMID: 37004526 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.

  PMID: 30858826 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.

  PMID: 30511337 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, serum, urine

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Disease; Coitus

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Valeria Raparelli, MD

  Experimental Medicine Department, Sapienza University of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Reseacher

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 14, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Locations

IT (1)