CClinicalTrials.gg
Status unknownNCT04239404Updated Jan 27, 2020

Prognostic Impact of PMI in Stable CAD Undergoing PCI

An observational study in Periprocedural Myocardial Injury, Coronary Artery Disease and Percutaneous Coronary Intervention, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-01-27.

Sponsored by Shanghai Zhongshan Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years to 85 Years
Sex
All
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Study summary

This is a single-center, observational, prospective study. This study aims to observe the effect of periprocedural myocardial injury on cardiovascular events in patients undergoing elective percutaneous coronary intervention, and to detect the levels of serum inflammatory factors before and after intervention to predict the occurrence of periprocedural myocardial injury and its association with cardiovascular events.

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Conditions studied

  • Periprocedural Myocardial Injury
  • Coronary Artery Disease
  • Percutaneous Coronary Intervention
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

In-patients with stable coronary artery disease undergoing elective percutaneous coronary intervention in Zhongshan Hospital will be enrolled.

Inclusion criteria

  • underwent elective coronary stenting
  • patients permit informed consents

Exclusion criteria

Exclusion Criteria:

  • acute STEMI
  • NYHA class III-IV heart failure
  • moderate-to-severe valvular disease
  • missing post-PCI troponin results
  • active infection, respiratory failure
  • liver dysfunction (liver enzyme >3xURL or bilirubin >2xURL),
  • malignancy and systemic connective tissue disease
  • unable to get a informed consents
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • PMI
  • non-PMI
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What researchers measure

Primary outcomes

  1. Major cardiac events

    cardiac death, target vessel revascularization, target lesion revascularization, non-fatal myocardial infarction, heart failure, angina pectoris

    Time frame: 12 months after PCI

Secondary outcomes

  1. Serum level of inflammatory factors

    Serum level of inflammatory factors including TNFα, IL-6 and so on.

    Time frame: 1 day after PCI

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Study locations

1 of 1 sites recruiting
  • 180 Fenglin Road
    Shanghai, Shanghai 200032, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04239404
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Jan 27, 2020
Start date
Jan 1, 2017
Primary completion
Dec 2020 (estimated)
Completion
May 2021 (estimated)
Last update
Jan 27, 2020

Study contacts

Zhangwei Chen, MD
Contact
chen.zhangwei@zs-hospital.sh.cn
+86 21 64041990
Danbo Lu, PhD
Contact
lu.danbo@zs-hospital.sh.cn
+86 21 64041990

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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