NCT04952740

Brief Summary

To evaluate the protective effect of IPC on the myocardial microcirculation response through IMR and the predictive value of IMR on the degree of myocardial reperfusion and the prognosis of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
Last Updated

July 9, 2021

Status Verified

January 1, 2014

Enrollment Period

12 months

First QC Date

June 29, 2021

Last Update Submit

July 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • IMR

    index of microcirculatory resistance measured during coronary intervention.

    detected immediately after percutaneous coronary intervention

Secondary Outcomes (1)

  • MACEs after PCI

    6 months

Study Arms (2)

Ischemic postconditioning

EXPERIMENTAL

Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) + immediate post-ischemic adaptation: 30 seconds balloon inflation and 30 seconds deflation for 3 cycles

Procedure: IPC+PCI

No Ischemic postconditioning

ACTIVE COMPARATOR

Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.)

Procedure: No IPC

Interventions

IPC+PCIPROCEDURE

Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) + immediate post-ischemic adaptation: 30 seconds balloon inflation and 30 seconds deflation for 3 cycles

Also known as: Ischemic postconditioning
Ischemic postconditioning
No IPCPROCEDURE

Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.

Also known as: Routine PCI
No Ischemic postconditioning

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years old, no gender limit;
  • First episode of STEMI (diagnostic criteria: ischemic chest pain lasting ≥30min; ST-segment elevation in two or more adjacent leads on the ECG or new left bundle branch block; with or without elevated myocardial markers), The onset time is within 12 hours, and emergency interventional treatment is planned;
  • Agree and cooperate to participate in this research.

You may not qualify if:

  • Old myocardial infarction;
  • Killip grade of cardiac function ≥ grade III or cardiogenic shock;
  • Systolic blood pressure ≤100mmHg;
  • Bradycardia, HR\<60pbm, or AVB above II degree;
  • Past history of asthma or severe COPD;
  • Severe liver and kidney dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University third hospital

Beijing, Beijing Municipality, 100089, China

Location

MeSH Terms

Interventions

Ischemic Postconditioning

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Lijun Lijun

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 7, 2021

Study Start

January 1, 2014

Primary Completion

December 31, 2014

Study Completion

June 30, 2015

Last Updated

July 9, 2021

Record last verified: 2014-01

Data Sharing

IPD Sharing
Will not share

Locations