ClinicalTrials.gg
RecruitingNCT04321512Updated Aug 17, 2026

Study of Circulating Monocytes in Patients With Ischemic Vascular Disease

An observational study in Myocardial Infarction, Stroke, Ischemic and Ischemia, sponsored by UConn Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by UConn Health · Observational

From the registry’s dates

  • Started Dec 2013; still recruiting 12 years 11 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Myocardial Infarction
  • Stroke, Ischemic
  • Ischemia
03

In context

Myocardial Infarction

2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.

This study's planned enrollment of 300 is below the median of 568 across 814 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

UConn Health is the lead sponsor of 187 studies on the registry; 18 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • STEMI Patients: Men and women aged 18 years and over, with symptoms, physical signs and 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.

Exclusion criteria

Exclusion Criteria:

  • Subjects who are unable to give (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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherThere is no intervention given to the subjects

    Not appicable

06

What researchers measure

Primary outcomes

  1. Hospitalization for Myocardial Infarction, Stroke, or death

    myocardial infarction, stroke or death

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2013 (actual). Primary completion is estimated for Dec 2027, 168 months after the start.

Of 296 non-industry observational studies under Myocardial Infarction, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 140. This study's planned 168 months is above that.

Counting every sponsor, half of 333 studies reached it within 48 months; a quarter within 17 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2020
First posted
Mar 25, 2020
StartActual
Dec 1, 2013
Primary completionEst.
Dec 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04321512
Lead sponsor
UConn Health
Responsible party
Bruce Liang (Professor of Medicine, Director Pat and Jim Calhoun Cardiovascular Center, UConn Health) — Principal investigator
First posted
Mar 25, 2020
Start date
Dec 1, 2013
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Aug 17, 2026

Study contacts

Kristen Siedlarz, MA
Contact
siedlarz@uchc.edu
860-679-7549
Adrianna G. Perez
Contact
adrperez@uchc.edu
Bruce Liang, MD
principal investigator · UConn Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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