Endothelial DysfunctioniphoneSPACENCT03583047
Intracoronary Features in the Prognosis of Endothelial Dysfunction and MACES in Population With Acute Coronary Syndrome
An observational study of Endothelial Dysfunction and Cardiovascular Risk Factor, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado at 1 site in Mexico.
Trial summary
Coronary Artery Disease (CAD) is common in Mexico, while morbidity and mortality is high. Drug therapy can relieve angina pain and stabilize plaque, but it is not able to re-flow a coronary artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Dysfunction, Cardiovascular Risk Factor, Coronary Syndrome, Acute
- How many people
- 45 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jan 2016to 15 Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Ischemic patients who are submitted to a percutaneous coronary intervention. * Atherosclerotic patients with coronary stent. * All the patients included are from the hospital "20 de noviembre, ISSSTE" in Mexico City.
Who may be able to join
- Coronary syndrome patients
- Patients with Endothelial dysfunction
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Mexico1 site
National Medical Center "20 de Noviembre", ISSSTE
Mexico City, 03100
About this study
Official title: Intracoronary Profile of Inflammation, Oxidative Stress and Endothelial Progenitor Cells (EPCs) in the Prognosis of Endothelial Dysfunction, Stent Re-stenosis and Cardiovascular Events in Population With Acute Coronary Syndrome.
Coronary Artery Disease (CAD) is common in Mexico, while morbidity and mortality is high. Drug therapy can relieve angina pain and stabilize plaque, but it is not able to re-flow a coronary artery. Balloon angioplasty and/or stent placement, re-establishes coronary blood flow; however, the risk of re-stenosis and/or development of new coronary events remains latent. Endothelial damage, reflected by the degree of endothelial dysfunction, inflammation and oxidative stress, promotes atherogenesis, which plays a central role in the pathophysiology of CAD. These mechanisms have been studied in animal models; however, it is widely unknown whether it influences the coronary circulation in humans. Therefore the present study explores the impact of an intracoronary profile of biomarkers of endothelial dysfunction, inflammation and oxidative stress on the prognosis of coronary remodeling and new adverse cardiovascular events in patients with chronic stable coronary syndrome undergoing angioplasty and stent placement.
Read the detailed description
Study design: Observational, longitudinal, analytic and prospective cohort study.
.With the Ethics and institutional investigation Committee acceptance, patients with stable coronary plaque or post-infarct angina with indicated coronary angiography and stent placement, from the Hemodynamic Unit from the National Medical Center "20 de Noviembre" of the Institute of Security and Social Services of State Workers (ISSSTE) are invited to participate. Patients who agree to participate in the study sign the informed consent. The independent variables will be the coronary profile components (oxidative stress, inflammation and endothelial disfunction biomarkers) and the consequence variables (dependent) will be the coronary and/or stent remodeling during the post-angioplasty with stent placement monitoring, Major Adverse Cardiovascular Events (MACE) during the post-angioplasty with stent placement monitoring period.
Clinical data:
to homogenize the study population respect to potentially confusing variables, information about sex, age, body mass index, vital signs. lipid profile. co-morbility presence like systemic arterial hypertension, diabetes mellitus, metabolic syndrome, drugs and troponin determination for stratify the acute coronaropathy.
Coronary Catheterization and sampling. The coronary catheterization (angioplasty with stent placement) is made under medical indication.
-Coronary catheterism: Is made in the hemodynamic laboratory. Asepsis, antisepsis and local anesthesia are performed in the intravascular approach area.
- Keywords
- MACE, EPCs, Cardiovascular risk, Endothelial dysfunction, Prognosis
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of any Major Adverse Cardiovascular Event (MACE)
Development of any MACE (a combination of major cardiovascular events, including death, heart failure, post-infarction angina, or new myocardial infarction) during a 3 months follow-up after angioplasty and stent placement.
Measured: 3 months
Secondary outcomes (1)
Development of any Major Adverse Cardiovascular Event (MACE)
Development of any MACE (A combination of any major cardiovascular events, including death, heart failure, post-infarction angina or new myocardial infarction) during a 6 months follow up after angioplasty and stent placement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start15 Jan 2016
- Primary completion10 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Sponsor type
- Other government
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Juan Antonio Suárez Cuenca, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Investigators
- Juan A. Suárez-Cuenca, Ph.D, Principal investigator, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583047
- Sponsor's protocol ID
- CONS0008-2014-1
- Acronym
- iphoneSPACE
- Status last verified
- Mar 2021
- First submitted
- 4 Jun 2018
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Profile of Inflammation, Oxidative Stress and Endothelial Progenitor Cells (EPCs) in the Prognosis of Endothelial Dysfunction, Stent Re-stenosis and Cardiovascular Events in Population With Acute Coronary Syndrome.
- ClinicalTrials.gov ID
- NCT03583047
- Acronym / sponsor ID
- iphoneSPACE / CONS0008-2014-1
- Keywords
- MACE, EPCs, Cardiovascular risk, Endothelial dysfunction, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del EstadoOther government
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 11 Jul 2018 (actual)
- 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.
Coronary Artery Disease (CAD) is common in Mexico, while morbidity and mortality is high. Drug therapy can relieve angina pain and stabilize plaque, but it is not able to re-flow a coronary artery. Balloon angioplasty and/or stent placement, re-establishes coronary blood flow; however, the risk of re-stenosis and/or development of new coronary events remains latent. Endothelial damage, reflected by the degree of endothelial dysfunction, inflammation and oxidative stress, promotes atherogenesis, which plays a central role in the pathophysiology of CAD. These mechanisms have been studied in animal models; however, it is widely unknown whether it influences the coronary circulation in humans. Therefore the present study explores the impact of an intracoronary profile of biomarkers of endothelial dysfunction, inflammation and oxidative stress on the prognosis of coronary remodeling and new adverse cardiovascular events in patients with chronic stable coronary syndrome undergoing angioplasty and stent placement.
Detailed description
Study design: Observational, longitudinal, analytic and prospective cohort study.
.With the Ethics and institutional investigation Committee acceptance, patients with stable coronary plaque or post-infarct angina with indicated coronary angiography and stent placement, from the Hemodynamic Unit from the National Medical Center "20 de Noviembre" of the Institute of Security and Social Services of State Workers (ISSSTE) are invited to participate. Patients who agree to participate in the study sign the informed consent. The independent variables will be the coronary profile components (oxidative stress, inflammation and endothelial disfunction biomarkers) and the consequence variables (dependent) will be the coronary and/or stent remodeling during the post-angioplasty with stent placement monitoring, Major Adverse Cardiovascular Events (MACE) during the post-angioplasty with stent placement monitoring period.
Clinical data:
to homogenize the study population respect to potentially confusing variables, information about sex, age, body mass index, vital signs. lipid profile. co-morbility presence like systemic arterial hypertension, diabetes mellitus, metabolic syndrome, drugs and troponin determination for stratify the acute coronaropathy.
Coronary Catheterization and sampling. The coronary catheterization (angioplasty with stent placement) is made under medical indication.
-Coronary catheterism: Is made in the hemodynamic laboratory. Asepsis, antisepsis and local anesthesia are performed in the intravascular approach area.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Ischemic patients who are submitted to a percutaneous coronary intervention. * Atherosclerotic patients with coronary stent. * All the patients included are from the hospital "20 de noviembre, ISSSTE" in Mexico City.
Key inclusion criteria (2 listed)
- Coronary syndrome patients
- Patients with Endothelial dysfunction
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of any Major Adverse Cardiovascular Event (MACE)
Time frame: 3 months
Development of any MACE (a combination of major cardiovascular events, including death, heart failure, post-infarction angina, or new myocardial infarction) during a 3 months follow-up after angioplasty and stent placement.
1 secondary outcome
Development of any Major Adverse Cardiovascular Event (MACE)
Time frame: 6 months
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 2 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Juan A. Suárez-Cuenca, Ph.D principal investigator
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
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 Endothelial Dysfunction and Cardiovascular Risk Factor, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado at 1 site in Mexico.
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 2 inclusion and 1 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 2 Mar 2021. 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 Mexico. 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?
Development of any Major Adverse Cardiovascular Event (MACE) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2021.