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

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ClinicalTrials.gov Identifier: NCT02737982
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : May 8, 2019
Sponsor:
Collaborator:
Ministry of Education, Universities and Research, Italy
Information provided by (Responsible Party):
Valeria Raparelli, University of Roma La Sapienza

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.


Condition or disease Intervention/treatment
Myocardial Ischemia Procedure: percutaneous coronary intervention

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Sex and Gender Differences in Ischemic Heart Disease: From Bench to Bedside EVA (Endocrine Vascular Disease Approach)
Actual Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Clinical outcomes including cardiovascular mortality, re-hospitalization and restenosis [ Time Frame: 12 months ]
  4. 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.


Biospecimen Retention:   Samples Without DNA
plasma, serum, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men and women who referred with a suspected IHD to the cath-lab for undergoing percutaneous coronary intervention
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737982


Contacts
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Contact: Valeria Raparelli, MD +393381603038 valeria.raparelli@uniroma1.it
Contact: Stefania Basili, MD +390649974678 stefania.basili@uniroma1.it

Locations
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Italy
Policlinico Umberto I , Sapienza University of Rome Recruiting
Rome, Italy, 00161
Contact: Andrea Lenzi, MD    +39-06-4452391-4469663    andrea.lenzi@uniroma1.it   
Contact: Valeria Raparelli, MD    +393381603038    valeria.raparelli@uniroma1.it   
Principal Investigator: Valeria Raparelli, MD         
Sub-Investigator: Andrea Lenzi, MD         
Sub-Investigator: Stefania Basili, MD         
Sub-Investigator: Gaetano Tanzilli, MD         
Sub-Investigator: Iacopo Carbone, MD         
Sub-Investigator: Pasquale Pignatelli, MD         
Sub-Investigator: Andrea Isidori, MD         
Sub-Investigator: Enrico Mangieri, MD         
Sub-Investigator: Alessandro Coppola, MD         
Sub-Investigator: Giuliano Bertazzoni, MD         
Sub-Investigator: Nicola Viceconte, MD         
Sponsors and Collaborators
University of Roma La Sapienza
Ministry of Education, Universities and Research, Italy
Investigators
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Principal Investigator: Valeria Raparelli, MD Experimental Medicine Department, Sapienza University of Rome

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Valeria Raparelli, University Reseacher, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02737982     History of Changes
Other Study ID Numbers: RBSI14HNVT
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Valeria Raparelli, University of Roma La Sapienza:
coronary heart disease
gender
platelet
microvascular dysfunction
sexual hormones
cardiac magnetic resonance
percutaneous coronary interventions
Additional relevant MeSH terms:
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Heart Diseases
Vascular Diseases
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Cardiovascular Diseases
Pathologic Processes
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases