Myocardial IschemiaEVANCT02737982
Sex and Gender Differences in Ischemic Heart Disease - Endocrine Vascular Disease Approach
An observational study of Myocardial Ischemia, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 509 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to Sep 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women who referred with a suspected IHD to the cath-lab for undergoing percutaneous coronary intervention
Who may be able to join
- 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
Who cannot join
- patients with expectancy of life less than 12 months
- active cancer
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- To assess the sex-gender difference in entity of microvascular reperfusion damage in patients with IHD undergoing urgent or elective PCI;
- To evaluate estrogen/androgen-dependent and -independent effects in gender-related differences on myocardial ischemia reperfusion damage occurring during PCI;
- 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;
- 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
- Being tested
- percutaneous coronary intervention
- Keywords
- coronary heart disease, gender, platelet, microvascular dysfunction, sexual hormones, cardiac magnetic resonance, percutaneous coronary interventions
- Medical subject headings
- Myocardial Ischemia, Coronary Disease, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionProcedure or surgery
coronary angiography with or without stent implantation, measurement of indexes of epicardial and microvascular reperfusion
| Study group | Role | What they receive |
|---|---|---|
| IHD Men | Men with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions Receives: Procedure: percutaneous coronary intervention | |
| IHD Women | Women with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions Receives: Procedure: percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade
angiographic assessment of coronary flow
Measured: baseline; within 1h from PCI
Secondary outcomes (4)
Sexual hormones levels in patients with IHD undergoing PCI
Evaluation and impact of sexual hormones levels in gender-related differences during myocardial reperfusion
Measured: baseline
Platelet activation markers including Thromboxane, soluble cluster designation 40 (CD40) Ligand and soluble P-selectin in patients with IHD undergoing PCI
Evaluation of Sex and gender differences in platelet function
Measured: baseline; within 1h from PCI; 12 months
Clinical outcomes including cardiovascular mortality, re-hospitalization and restenosis
Measured: 12 months
Microvascular dysfunction assessed by cardiac magnetic resonance
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.
Measured: 7 days from percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 509 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Universities and Research, Italy
- Responsible party
- Principal investigator, Valeria Raparelli, University of Roma La Sapienza
- Investigators
- Valeria Raparelli, MD, Principal investigator, Experimental Medicine Department, Sapienza University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737982
- Sponsor's protocol ID
- RBSI14HNVT
- Acronym
- EVA
- Status last verified
- Nov 2020
- First submitted
- 1 Apr 2016
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 37004526Raparelli 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.
PubMed 30858826Raparelli 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.
PubMed 30511337
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex and Gender Differences in Ischemic Heart Disease: From Bench to Bedside EVA (Endocrine Vascular Disease Approach)
- ClinicalTrials.gov ID
- NCT02737982
- Acronym / sponsor ID
- EVA / RBSI14HNVT
- Conditions
- Myocardial Ischemia
- Keywords
- coronary heart disease, gender, platelet, microvascular dysfunction, sexual hormones, cardiac magnetic resonance, percutaneous coronary interventions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Ministry of Education, Universities and Research, Italy
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the sex-gender difference in entity of microvascular reperfusion damage in patients with IHD undergoing urgent or elective PCI;
- To evaluate estrogen/androgen-dependent and -independent effects in gender-related differences on myocardial ischemia reperfusion damage occurring during PCI;
- 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;
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IHD Men | – | Procedure: percutaneous coronary interventionMen with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions |
| IHD Women | – | Procedure: percutaneous coronary interventionWomen with acute or chronic ischemic heart disease undergoing percutaneous coronary interventions |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women who referred with a suspected IHD to the cath-lab for undergoing percutaneous coronary intervention
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- patients with expectancy of life less than 12 months
- active cancer
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous coronary interventioncoronary angiography with or without stent implantation, measurement of indexes of epicardial and microvascular reperfusion | Procedure or surgery | IHD Men, IHD Women |
Primary outcome
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
4 secondary outcomes
Sexual hormones levels in patients with IHD undergoing PCI
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Derived from this study: PubMed 37004526Raparelli 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.
- Derived from this study: PubMed 30858826Raparelli 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.
- Derived from this study: PubMed 30511337Raparelli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valeria Raparelli, MD principal investigator
Experimental Medicine Department, Sapienza University of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of corrected Thrombolysis In Myocardial Infarction frame count and myocardial blush grade (time frame: baseline; within 1h from PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02737982, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.