NCT05043558

Brief Summary

To explore the protective effect of prostaglandin sodium on coronary microcirculation function and ventricular remodeling after reperfusion treatment of acute ST-segment elevation myocardial infarction.

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
220

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2022

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

August 25, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2022

Completed
Last Updated

September 14, 2021

Status Verified

August 1, 2021

Enrollment Period

9 days

First QC Date

August 25, 2021

Last Update Submit

September 4, 2021

Conditions

Keywords

Beprostaglandin sodium

Outcome Measures

Primary Outcomes (1)

  • ultrasound and CMR to assess the characteristics of myocardial infarction

    Q-LAB Scale Scale calculation score

    3 years

Study Arms (2)

beprostaglandin sodium

EXPERIMENTAL
Drug: beprostaglandin sodium

control group

NO INTERVENTION

Interventions

beprostaglandin sodium

beprostaglandin sodium

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Meet the diagnostic criteria for acute ST-segment elevation myocardial infarction: ①The onset of ischemic chest pain lasts for more than 30 minutes and cannot be relieved by taking nitroglycerin; ②The ECG has two or more ST-segment elevations in adjacent leads , Limb leads ≥ 1mm, pectoral leads ≥ 2mm; or newly-appearing left bundle branch block; ③The increase in serum markers of myocardial necrosis is at least twice the normal value; (2) Coronary angiography confirmed acute myocardial infarction; (3) Direct PCI treatment within 12 hours of onset; (4) Complete clinical and radiographic data.

You may not qualify if:

  • (1) Those who do not cooperate in the inspection, have poor compliance, and cannot guarantee the completion of the test; (2) Persons with consciousness impairment, obvious intellectual impairment and mental abnormality; (3) With metal foreign bodies, such as metal prostheses, intraocular metal foreign bodies, intracranial aneurysm clamps, etc.; (4) Those who suffer from closure phobia; (5) Those who have had a history of myocardial infarction, PCI treatment, or coronary artery bypass graft; (6) Factors affecting the changes in the ST segment of the electrocardiogram: complete left bundle branch block, pre-excitation syndrome, pacemaker electrocardiogram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen People' S Hospital

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Huadong Liu, doctor

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2021

First Posted

September 14, 2021

Study Start

January 1, 2022

Primary Completion

January 10, 2022

Study Completion

January 12, 2022

Last Updated

September 14, 2021

Record last verified: 2021-08

Locations