Myocardial InfarctionNCT04321512
Study of Circulating Monocytes in Patients With Ischemic Vascular Disease
An observational study of Myocardial Infarction and Stroke, Ischemic, run by UConn Health at 1 site in United States.
Trial summary
The purpose of this research study is to discover the functions of circulating white blood cells, called monocytes, and associated circulating substances in heart attack and ischemic stroke patients. Ischemic Strokes (clots) occur as a result of an obstruction within a blood vessel supplying blood to the brain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Stroke, Ischemic, Ischemia
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2013to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment will take place at UConn Health Center. The target populations of 300 will be those with STEMI (60 subjects), NSTEMI (60 subjects) and SCAD (60 subjects), ischemic stroke (60 subjects), and age-matched non-disease subjects (60 subjects). The researchers anticipate that 5% of all recruited subjects will be African American and another 3% will be Latinos and Asians. This represents the distribution of populations recruited in the past for heart disease studies.
Who may be able to join
- STEMI Patients: Men and women aged 18 years and over, with symptoms, physical signs and ECG changes characteristic of STEMI.
- NSTEMI Patients: Men and women aged 18 years and over, with symptoms, physical signs and ECG changes characteristic of NSTEMI.
- Stable CAD Patients: men and women aged 18 years and older with coronary artery disease proven by prior MI history, angiography or stress test but without any unstable angina or acute coronary syndrome.
- Ischemic Stroke Patients: Men and women aged 18 years and over, with symptoms, physical signs and CT/MRI changes characteristic of ischemic stroke.
- Healthy Controls: Men and women aged 18 years and over, without heart failure, coronary disease, hypertension, diabetes or other chronic diseases. Control subjects will be recruited from within the community of UConn Health via advertisement.
Who cannot join
- Subjects who are unable to give informed consent (with the exception of the ischemic stroke arm patients, see Protocol Design below) and pregnant subjects.
- Subjects who had any history of embolic, ischemic or hemorrhagic stroke within the last 12 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Adrianna G. Perez contact
United States1 site, 1 recruiting
- Recruiting
University of Connecticut Health Center
Farmington, Connecticut, 06030
Adrianna Perez, 860-679-7549, adrperez@uchc.edu
Bruce Liang, MD
About this study
The purpose of this research study is to discover the functions of circulating white blood cells, called monocytes, and associated circulating substances in heart attack and ischemic stroke patients. Ischemic Strokes (clots) occur as a result of an obstruction within a blood vessel supplying blood to the brain. A type of monocyte carrying a surface marker called "P2X4" helps the immune system sense and respond to danger signals from the body such as heart muscle and brain tissue injuries.
The researchers expect to learn more about how these monocyte cells react to heart and brain tissue injury, and how the cells may then produce proteins or other chemical substances which promote the healing of heart muscle after heart attack and brain tissue after an ischemic stroke.
Read the detailed description
The research objective here is to perform a pilot study in determining the level of such monocytes in MI/stroke patients at various times after the acute ischemic event. As controls, both stable coronary disease and healthy control subjects will be enrolled in whom these circulating cells will be determined.
The research objective will be accomplished via the following specific aim:
The specific aim will determine the levels of P2X4 monocytes, Flt-1/VEGFR-1 and CD13 monocytes. The researchers may collect three blood samples at various time points. The samples will be collected within 48 hours of admission to the hospital, 2-14, and 30-120 days following MI/stroke. As a control, levels of P2X4, Flt-1+ (VEGFR-1+) and CD13 monocytes in age- matched healthy subjects and in SCAD subjects will be used. Additionally for CD13 monocytes, the researchers plan to test if CD13 is phosphorylated in the circulating monocytes of patients who have undergone myocardial/cerebral infarction and determine its utility as a biomarker of infarct size.
Although the study is not designed to determine whether those MI/stroke patients within the top quartile of P2X4 or Flt-1+ (VEGFR-1+) or CD13 monocyte levels are more prone to develop severe tissue or organ dysfunction, the study will collect baseline and subsequent clinical data set and should position the study team to test this hypothesis in the future.
The researchers might expect to show that MI/stroke patients have a higher level of P2X4, Flt-1+ (VEGFR-1+) and/or CD13 monocytes as well as circulating cytokines and metabolites as compared to SCAD and age-matched healthy controls. The researchers might also expect that thrombectomy samples from ischemic stroke patients will have higher inflammatory cytokines and inflammatory monocytes.
Objectives:
- To obtain blood samples from STEMI patients for determination of P2X4, Flt-1+ (VEGFR-1+) and CD13 monocyte levels as well as circulating cytokines and metabolites on the days: 1(within 48 hours of admission), 2-14, and 30-120 days after the MI.
- To obtain blood samples from NSTEMI (non-ST segment elevation MI) patients for determination of P2X4, Flt-1+ (VEGFR-1+) and CD13 monocyte levels as well as circulating cytokines and metabolites on the days: 1(within 48 hours of admission hospital), 2-14, and 30-120 days after the MI.
- To obtain blood samples from ischemic stroke patients for determination of P2X4, Flt-1+ (VEGFR-1+) and CD13 monocyte levels as well as circulating cytokines and metabolites on the days: 1(within 48 hours of admission), 2-14, and 30-120 days after the ischemic event. In addition, thrombectomy samples which are normally discarded, when obtained and available, will be used.
- To obtain blood samples from age-matched SCAD and healthy control subjects for a one-time determination of P2X4, Flt-1+ (VEGFR-1+) and CD13 monocyte as well as circulating cytokines and metabolites levels.
- To compare the levels in STEMI, NSTEMI and ischemic stroke vs. those of SCAD and healthy control subjects.
Hypotheses:
STEMI, NSTEMI and stroke subjects will have a higher level of P2X4, Flt-1+ (VEGFR- 1+) and CD13 monocytes than age-matched SCAD and healthy control subjects.
- Conditions
- Myocardial Infarction, Stroke, Ischemic, Ischemia
- Being tested
- There is no intervention given to the subjects
- Medical subject headings
- Myocardial Infarction, Ischemic Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention given to the subjectsOther
Not appicable
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for Myocardial Infarction, Stroke, or death
myocardial infarction, stroke or death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Dec 2013
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Liang, UConn Health
- Investigators
- Bruce Liang, MD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321512
- Sponsor's protocol ID
- 13-119-2
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2020
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Circulating Monocytes in Patients With Ischemic Vascular Disease
- ClinicalTrials.gov ID
- NCT04321512
- Acronym / sponsor ID
- 13-119-2
- Conditions
- Myocardial Infarction, Stroke, Ischemic, Ischemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 25 Mar 2020 (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.
The purpose of this research study is to discover the functions of circulating white blood cells, called monocytes, and associated circulating substances in heart attack and ischemic stroke patients. Ischemic Strokes (clots) occur as a result of an obstruction within a blood vessel supplying blood to the brain. A type of monocyte carrying a surface marker called "P2X4" helps the immune system sense and respond to danger signals from the body such as heart muscle and brain tissue injuries.
The researchers expect to learn more about how these monocyte cells react to heart and brain tissue injury, and how the cells may then produce proteins or other chemical substances which promote the healing of heart muscle after heart attack and brain tissue after an ischemic stroke.
Detailed description
The research objective here is to perform a pilot study in determining the level of such monocytes in MI/stroke patients at various times after the acute ischemic event. As controls, both stable coronary disease and healthy control subjects will be enrolled in whom these circulating cells will be determined.
The research objective will be accomplished via the following specific aim:
The specific aim will determine the levels of P2X4 monocytes, Flt-1/VEGFR-1 and CD13 monocytes. The researchers may collect three blood samples at various time points. The samples will be collected within 48 hours of admission to the hospital, 2-14, and 30-120 days following MI/stroke. As a control, levels of P2X4, Flt-1+ (VEGFR-1+) and CD13 monocytes in age- matched healthy subjects and in SCAD subjects will be used. Additionally for CD13 monocytes, the researchers plan to test if CD13 is phosphorylated in the circulating monocytes of patients who have undergone myocardial/cerebral infarction and determine its utility as a biomarker of infarct size.
Although the study is not designed to determine whether those MI/stroke patients within the top quartile of P2X4 or Flt-1+ (VEGFR-1+) or CD13 monocyte levels are more prone to develop severe tissue or organ dysfunction, the study will collect baseline and subsequent clinical data set and should position the study team to test this hypothesis in the future.
The researchers might expect to show that MI/stroke patients have a higher level of P2X4, Flt-1+ (VEGFR-1+) and/or CD13 monocytes as well as circulating cytokines and metabolites as compared to SCAD and age-matched healthy controls. The researchers might also expect that thrombectomy samples from ischemic stroke patients will have higher inflammatory cytokines and inflammatory monocytes.
Objectives:
- To obtain blood samples from STEMI patients for determination of P2X4, Flt-1+ (VEGFR-1+) and CD13 monocyte levels as well as circulating cytokines and metabolites on the days: 1(within 48 hours of admission), 2-14, and 30-120 days after the MI.
- To obtain blood samples from NSTEMI (non-ST segment elevation MI) patients for determination of P2X4, Flt-1+ (VEGFR-1+) and CD13 monocyte levels as well as circulating cytokines and metabolites on the days: 1(within 48 hours of admission hospital), 2-14, and 30-120 days after the MI.
- To obtain blood samples from ischemic stroke patients for determination of P2X4, Flt-1+ (VEGFR-1+) and CD13 monocyte levels as well as circulating cytokines and metabolites on the days: 1(within 48 hours of admission), 2-14, and 30-120 days after the ischemic event. In addition, thrombectomy samples which are normally discarded, when obtained and available, will be used.
- To obtain blood samples from age-matched SCAD and healthy control subjects for a one-time determination of P2X4, Flt-1+ (VEGFR-1+) and CD13 monocyte as well as circulating cytokines and metabolites levels.
- To compare the levels in STEMI, NSTEMI and ischemic stroke vs. those of SCAD and healthy control subjects.
Hypotheses:
STEMI, NSTEMI and stroke subjects will have a higher level of P2X4, Flt-1+ (VEGFR- 1+) and CD13 monocytes than age-matched SCAD and healthy control subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment will take place at UConn Health Center. The target populations of 300 will be those with STEMI (60 subjects), NSTEMI (60 subjects) and SCAD (60 subjects), ischemic stroke (60 subjects), and age-matched non-disease subjects (60 subjects). The researchers anticipate that 5% of all recruited subjects will be African American and another 3% will be Latinos and Asians. This represents the distribution of populations recruited in the past for heart disease studies.
Key inclusion criteria (5 listed)
- STEMI Patients: Men and women aged 18 years and over, with symptoms, physical signs and ECG changes characteristic of STEMI.
- NSTEMI Patients: Men and women aged 18 years and over, with symptoms, physical signs and ECG changes characteristic of NSTEMI.
- Stable CAD Patients: men and women aged 18 years and older with coronary artery disease proven by prior MI history, angiography or stress test but without any unstable angina or acute coronary syndrome.
- Ischemic Stroke Patients: Men and women aged 18 years and over, with symptoms, physical signs and CT/MRI changes characteristic of ischemic stroke.
- Healthy Controls: Men and women aged 18 years and over, without heart failure, coronary disease, hypertension, diabetes or other chronic diseases. Control subjects will be recruited from within the community of UConn Health via advertisement.
Key exclusion criteria (2 listed)
- Subjects who are unable to give informed consent (with the exception of the ischemic stroke arm patients, see Protocol Design below) and pregnant subjects.
- Subjects who had any history of embolic, ischemic or hemorrhagic stroke within the last 12 months.
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 |
|---|---|---|
| There is no intervention given to the subjectsNot appicable | Other | – |
Primary outcome
Hospitalization for Myocardial Infarction, Stroke, or death
Time frame: 3 years
myocardial infarction, stroke or death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- 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.
Adrianna G. Perez contact
Bruce Liang, MD principal investigator
UConn Health
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 Infarction and Stroke, Ischemic, run by UConn Health at 1 site in United States.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen Siedlarz, MA (860-679-7549, siedlarz@uchc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization for Myocardial Infarction, Stroke, or death (time frame: 3 years). 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 17 Aug 2026.