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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

Tracking Information
First Submitted Date April 1, 2016
First Posted Date April 14, 2016
Last Update Posted Date May 8, 2019
Actual Study Start Date April 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 13, 2016)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02737982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 14, 2016)
  • 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
  • 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
  • Clinical outcomes including cardiovascular mortality, re-hospitalization and restenosis [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: April 13, 2016)
  • 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
  • Platelet activation markers including Thromboxane, soluble 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
  • Clinical outcomes including cardiovascular mortality, re-hospitalization and restenosis [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Retention:   Samples Without DNA
Description:
plasma, serum, urine
Sampling Method Probability Sample
Study Population Men and women who referred with a suspected IHD to the cath-lab for undergoing percutaneous coronary intervention
Condition Myocardial Ischemia
Intervention Procedure: percutaneous coronary intervention
coronary angiography with or without stent implantation, measurement of indexes of epicardial and microvascular reperfusion
Study Groups/Cohorts
  • IHD Men
    Men with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions
    Intervention: Procedure: percutaneous coronary intervention
  • IHD Women
    Women with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions
    Intervention: Procedure: percutaneous coronary intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 13, 2016)
210
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Valeria Raparelli, MD +393381603038 valeria.raparelli@uniroma1.it
Contact: Stefania Basili, MD +390649974678 stefania.basili@uniroma1.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02737982
Other Study ID Numbers RBSI14HNVT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Valeria Raparelli, University of Roma La Sapienza
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
PRS Account University of Roma La Sapienza
Verification Date May 2019