NCT04321512

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Dec 2013Dec 2027

Study Start

First participant enrolled

December 1, 2013

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 14, 2025

Status Verified

July 1, 2025

Enrollment Period

14 years

First QC Date

March 23, 2020

Last Update Submit

August 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospitalization for Myocardial Infarction, Stroke, or death

    myocardial infarction, stroke or death

    3 years

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, whole blood

MeSH Terms

Conditions

Myocardial InfarctionIschemic StrokeIschemia

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Bruce Liang, MD

    UConn Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fahad Shah, BSc.

CONTACT

Adrianna G. Perez

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Director Pat and Jim Calhoun Cardiovascular Center

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

December 1, 2013

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations