CaIMRNCT04984915
The Usefulness of CaIMR in Patients With STEMI
An observational study of CaIMR and Prognosis, run by Zhongnan Hospital at 1 site in China.
Trial summary
The coronary artery system is composed of three different types of blood vessels, namely epicardial arteries, arterioles and capillaries. Compared with epicardial arteries, arterioles and capillaries are lower than the resolution of current angiography systems, so angiography cannot be used for visualization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CaIMR, Prognosis, ST-segment Elevation Myocardial Infarction
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2022to 1 Dec 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet the inclusion and exclusion criteria are included in the study.
Who may be able to join
- Patients who are clinically diagnosed with acute ST-segment elevation myocardial infarction and are planned to undergo PCI;
- Volunteer to participate and sign the informed consent
Who cannot join
- Coronary angiography suggests that it is not suitable for PCI;
- Have performed CABG surgery in the past;
- Lesion of left or right coronary ostium;
- The target vessel is an infarct-related artery (old or acute myocardial infarction recovery period);
- The immediate effect of target vessel PCI is not ideal (such as: final TIMI blood flow <grade 3, dissection with restricted blood flow, side branch occlusion with diameter> 1.5 mm, distal embolism or thrombus shown by angiography);
- Severe systemic infection;
- Patients with malignant wasting disease whose estimated survival time is less than 1 year.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Lei Zheng, PhD, 027-67812787, znyyll@126.com
About this study
Official title: The Long-term Prognostic Value of CaIMR in Patients With ST-segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention
The coronary artery system is composed of three different types of blood vessels, namely epicardial arteries, arterioles and capillaries. Compared with epicardial arteries, arterioles and capillaries are lower than the resolution of current angiography systems, so angiography cannot be used for visualization. Existing studies have shown that coronary microcirculation plays an extremely important role in maintaining full myocardial perfusion. Coronary microvascular disorders can lead to myocardial hypoperfusion and ischemia, and are related to the poor prognosis of patients with coronary heart disease. At present, there is no technology that can directly detect the state of the coronary microcirculation in the human body, but the coronary microcirculation function can be indirectly assessed through two invasive and non-invasive methods. Among them, the index of microcirculation resistance (IMR) is widely used to evaluate coronary microcirculation function [3]. However, in the case of epicardial stenosis, accurate determination of IMR requires knowledge of coronary artery contraction pressure (Pw). However, measuring IMR is an invasive examination technique, and measuring IMR requires high technical requirements for the operator. Therefore, the CaIMR value obtained by AI technology can well overcome this limitation, and the existing data show that the CaIMR value has a good correlation with the IMR value. However, CaIMR has a clinical prognosis for patients with acute ST-segment elevation myocardial infarction. The predictive value of CaIMR has not yet been explored. This project aims to evaluate the application value of CaIMR in predicting the occurrence of adverse cardiovascular events in patients with acute ST-segment elevation myocardial infarction after percutaneous coronary intervention.
- Conditions
- CaIMR, Prognosis, ST-segment Elevation Myocardial Infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite endpoint of all-cause death and heart failure rehospitalization
The composite endpoint of all-cause death and heart failure rehospitalization
Measured: 1 year after surgery
Secondary outcomes (7)
The composite endpoint of all-cause death and heart failure rehospitalization
The composite endpoint of all-cause death and heart failure rehospitalization
Measured: 1 month after surgery
All-cause death
All-cause death
Measured: 1 year after surgery
All-cause death
All-cause death
Measured: 1 month after surgery
Heart failure rehospitalization
Heart failure rehospitalization
Measured: 1 year after surgery
Heart failure rehospitalization
Heart failure rehospitalization
Measured: 1 month after surgery
Cardiogenic Rehospitalization
Cardiogenic Rehospitalization
Measured: 1 year after surgery
Cardiogenic Rehospitalization
Cardiogenic Rehospitalization
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start15 May 2022 (estimated)
- Primary completion15 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaIMRStudies of the same condition, open and under way.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhibing Lu, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984915
- Sponsor's protocol ID
- 2021075
- Status last verified
- Feb 2022
- First submitted
- 6 Jun 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Prognostic Value of CaIMR in Patients With ST-segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04984915
- Acronym / sponsor ID
- 2021075
- Conditions
- CaIMR, Prognosis, ST-segment Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 2 Aug 2021 (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.
The coronary artery system is composed of three different types of blood vessels, namely epicardial arteries, arterioles and capillaries. Compared with epicardial arteries, arterioles and capillaries are lower than the resolution of current angiography systems, so angiography cannot be used for visualization. Existing studies have shown that coronary microcirculation plays an extremely important role in maintaining full myocardial perfusion. Coronary microvascular disorders can lead to myocardial hypoperfusion and ischemia, and are related to the poor prognosis of patients with coronary heart disease. At present, there is no technology that can directly detect the state of the coronary microcirculation in the human body, but the coronary microcirculation function can be indirectly assessed through two invasive and non-invasive methods. Among them, the index of microcirculation resistance (IMR) is widely used to evaluate coronary microcirculation function [3]. However, in the case of epicardial stenosis, accurate determination of IMR requires knowledge of coronary artery contraction pressure (Pw). However, measuring IMR is an invasive examination technique, and measuring IMR requires high technical requirements for the operator. Therefore, the CaIMR value obtained by AI technology can well overcome this limitation, and the existing data show that the CaIMR value has a good correlation with the IMR value. However, CaIMR has a clinical prognosis for patients with acute ST-segment elevation myocardial infarction. The predictive value of CaIMR has not yet been explored. This project aims to evaluate the application value of CaIMR in predicting the occurrence of adverse cardiovascular events in patients with acute ST-segment elevation myocardial infarction after percutaneous coronary intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the inclusion and exclusion criteria are included in the study.
Key inclusion criteria (2 listed)
- Patients who are clinically diagnosed with acute ST-segment elevation myocardial infarction and are planned to undergo PCI;
- Volunteer to participate and sign the informed consent
Key exclusion criteria (7 listed)
- Coronary angiography suggests that it is not suitable for PCI;
- Have performed CABG surgery in the past;
- Lesion of left or right coronary ostium;
- The target vessel is an infarct-related artery (old or acute myocardial infarction recovery period);
- The immediate effect of target vessel PCI is not ideal (such as: final TIMI blood flow <grade 3, dissection with restricted blood flow, side branch occlusion with diameter> 1.5 mm, distal embolism or thrombus shown by angiography);
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
The composite endpoint of all-cause death and heart failure rehospitalization
Time frame: 1 year after surgery
The composite endpoint of all-cause death and heart failure rehospitalization
7 secondary outcomes
The composite endpoint of all-cause death and heart failure rehospitalization
Time frame: 1 month after surgery
All-cause death
Time frame: 1 year after surgery
All-cause death
Time frame: 1 month after surgery
Heart failure rehospitalization
Time frame: 1 year after surgery
Heart failure rehospitalization
Time frame: 1 month after surgery
Cardiogenic Rehospitalization
Time frame: 1 year after surgery
Cardiogenic Rehospitalization
Time frame: 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
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A Multi-center, Real-World Clinical Trial of caIMR on Two Specific Kinds of Patients.
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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 CaIMR and Prognosis, run by Zhongnan 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 7 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 9 Feb 2022. 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 Zhibing Lu, MD, PhD (8615997405817, luzhibing222@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite endpoint of all-cause death and heart failure rehospitalization (time frame: 1 year after surgery). 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 9 Feb 2022.