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

November 9, 2020 updated by: Valeria Raparelli, University of Roma La Sapienza

Sex and Gender Differences in Ischemic Heart Disease: From Bench to Bedside EVA (Endocrine Vascular Disease Approach)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

509

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00161
        • Policlinico Umberto I , Sapienza University of Rome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IHD Men
Men 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
IHD Women
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade
Time Frame: baseline; within 1h from PCI
angiographic assessment of coronary flow
baseline; within 1h from PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual hormones levels in patients with IHD undergoing PCI
Time Frame: baseline
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
Time Frame: baseline; within 1h from PCI; 12 months
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
Time Frame: 12 months
12 months
Microvascular dysfunction assessed by cardiac magnetic resonance
Time Frame: 7 days from percutaneous coronary intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Collaborators

Ministry of Education, Universities and Research, Italy

Investigators

  • Principal Investigator: Valeria Raparelli, MD, Experimental Medicine Department, Sapienza University of Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBSI14HNVT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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