Periprocedural Myocardial InjuryNCT04239404
Prognostic Impact of PMI in Stable CAD Undergoing PCI
An observational study of Periprocedural Myocardial Injury and Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Periprocedural Myocardial Injury, Coronary Artery Disease, Percutaneous Coronary Intervention
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In-patients with stable coronary artery disease undergoing elective percutaneous coronary intervention in Zhongshan Hospital will be enrolled.
Who may be able to join
- underwent elective coronary stenting
- patients permit informed consents
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032
About this study
Official title: The Prognostic Impact of Periprocedural Myocardial Injury in Stable Coronary Artery Disease Patients Undergoing Elective Percutaneous Coronary Intervention
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.
- Conditions
- Periprocedural Myocardial Injury, Coronary Artery Disease, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PMI | Not described | |
| non-PMI | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiac events
cardiac death, target vessel revascularization, target lesion revascularization, non-fatal myocardial infarction, heart failure, angina pectoris
Measured: 12 months after PCI
Secondary outcomes (1)
Serum level of inflammatory factors
Serum level of inflammatory factors including TNFα, IL-6 and so on.
Measured: 1 day after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jan 2017
- Primary completionDec 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprocedural Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239404
- Sponsor's protocol ID
- PMI-CAD-PCI
- Status last verified
- Jan 2020
- First submitted
- 20 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Impact of Periprocedural Myocardial Injury in Stable Coronary Artery Disease Patients Undergoing Elective Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04239404
- Acronym / sponsor ID
- PMI-CAD-PCI
- Conditions
- Periprocedural Myocardial Injury, Coronary Artery Disease, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMI | – | – |
| non-PMI | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In-patients with stable coronary artery disease undergoing elective percutaneous coronary intervention in Zhongshan Hospital will be enrolled.
Key inclusion criteria (2 listed)
- underwent elective coronary stenting
- patients permit informed consents
Key exclusion criteria (8 listed)
- acute STEMI
- NYHA class III-IV heart failure
- moderate-to-severe valvular disease
- missing post-PCI troponin results
- active infection, respiratory failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major cardiac events
Time frame: 12 months after PCI
cardiac death, target vessel revascularization, target lesion revascularization, non-fatal myocardial infarction, heart failure, angina pectoris
1 secondary outcome
Serum level of inflammatory factors
Time frame: 1 day after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periprocedural Myocardial Injury and Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhangwei Chen, MD (+86 21 64041990, chen.zhangwei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiac events (time frame: 12 months after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.