NCT03939338

Brief Summary

This study aims to determine whether combination with regulatory T cell (Treg) levels and cardiac magnetic resonance imaging (CMR) are predictive of the severity of reperfusion injury following myocardial infarction and the prognosis in STEMI patients receiving primary percutaneous coronary intervention (PPCI).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

2.2 years

First QC Date

May 3, 2019

Last Update Submit

June 25, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • MACE (major adverse cardiovascular events)

    nonfatal or fatal myocardial infarction, revascularization, cardiac death, nonfatal or fatal stroke, all cause of death

    12 months

Secondary Outcomes (1)

  • adverse cardiac remodeling

    6 months

Study Arms (1)

Participates

Other: Treg levels and CMR results

Interventions

This is an observational study. Exposure: Different Treg levels and CMR results.

Participates

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to Beijing Friendship Hospital,Capital Medical University with a confirmed STEMI diagnosis undergoing primary percutaneous coronary intervention

You may qualify if:

  • Confirmed STEMI diagnosis
  • Undergoing primary percutaneous coronary intervention (presenting \<12 hours after symptom onset)
  • Patients were able to complete cardiac magnetic resonance imaging (CMR) and speckle tracking imaging echocardiogram (STE) examinations
  • Patients agreed and provided informed consent

You may not qualify if:

  • Previous myocardial infarction or revascularization (PCI or CABG)
  • Congestive heart failure with LVEF\<40%
  • Atrial fibrillation
  • Renal insufficiency (GFR \< 30 ml/min/1.73m\^2)
  • Acute infectious diseases within nearly 3 months
  • Rheumatic immune system diseases
  • Malignant tumors
  • Claustrophobia
  • Contraindicated to CMR
  • Patients do not agree to be included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (1)

  • Zhang Y, Gao H, Liu L, Li S, Hua B, Lan D, He Y, Li J, Chen H, Li W, Li H. Regulatory T Cell as Predictor of Intramyocardial Hemorrhage in STEMI Patients after Primary PCI. Rev Cardiovasc Med. 2023 Jul 14;24(7):205. doi: 10.31083/j.rcm2407205. eCollection 2023 Jul.

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Reperfusion Injury

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCardiomyopathiesReperfusion InjuryPostoperative Complications

Central Study Contacts

Hongwei Li, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 6, 2019

Study Start

July 1, 2019

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

June 26, 2019

Record last verified: 2019-06

Locations