Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04321512 |
Other study ID # |
13-119-2 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 1, 2013 |
Est. completion date |
February 1, 2025 |
Study information
Verified date |
December 2023 |
Source |
UConn Health |
Contact |
Michelle Izydorczak, BA,MA |
Phone |
860-679-7549 |
Email |
izydorczak[@]uchc.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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. 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.
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.