Coronary Heart DiseaseEARLYMYOAMRNCT05653765
Prognostic Value of the AMR Measured After PPCI in STEMI Patients
An observational study of Coronary Heart Disease and ST Elevation Myocardial Infarction, run by Henan Institute of Cardiovascular Epidemiology at 5 sites in China.
Trial summary
The goal of this observational study is to learn about in STEMI with Primary PCI Patients. The main questions it aims to answer are: To determine the value of AMR in predicting the long-term clinical prognosis of patients with STEMI after PPCI, and to find the best cut-off value. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, ST Elevation Myocardial Infarction
- How many people
- 2,663 participants
- Where
- 5 sitesChina
- Study dates
- 20 Dec 2022to 20 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent PPCI due to STEMI in several chest pain centers in China from January 1, 2012 to October 1, 2022
Who may be able to join
- Aged 18 or older
- Type 1 myocardial infarction
- Receive PPCI
Who cannot join
- Failed to identify culprit vessels.
- Structural heart disease with moderate to severe aortic valve or mitral regurgitation and or stenosis that may affect cardiac function
- Dialysis patients with severe renal insufficiency
- Severe and uncontrollable arrhythmia
- Complicated with dilated cardiomyopathy
- Unable to tolerate dual antiplatelet therapy
Show all 9Show fewer
- Severe and uncontrollable anemia
- Hyperthyroidism
- TIMI blood flow 0-1 grade after PPCI
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Renji Hospital, School of Medicine, Shanghai Jiao Tong University,
Shanghai, Shanghai Municipality
Shangqiu first people's Hospital
Shangqiu, Henan, 476000
Department of Cardiology, First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan
Yongcheng Central Hospital
Yongcheng, Henan
Fuwai central China cardiovascular Hospital
Zhengzhou, Henan
About this study
Official title: Prognostic Value of the Angio-based Microvascular Resistance Use One Single Angiographic View Measured After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients
The goal of this observational study is to learn about in STEMI with Primary PCI Patients. The main questions it aims to answer are:
- To determine the value of AMR in predicting the long-term clinical prognosis of patients with STEMI after PPCI, and to find the best cut-off value.
- Analyze the factors of PPCI affecting AMR and explore the effective measures of PPCI microcirculation protection.
Radiographic images of STEMI receiving primary PCI treatment in several chest pain centers in China will be included. The last image of the infarct-related vessel will be used as a target to calculate its AMR. The relationship between AMR and long-term clinical prognosis was analyzed.
- Medical subject headings
- Coronary Disease, ST Elevation Myocardial Infarction
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 |
|---|---|---|
| diagnostic cohort/derivation cohort | The diagnostic/derivation cohort included STEMI patients who underwent PCI within 12 hours and CMR. The optimal AMR cutoff value for diagnosing CMD using CMR was determined by analyzing ROC curves. | |
| prognostic cohort/validation cohort | The prognostic cohort enrolled STEMI patients who underwent PPCI within 12 hours. All patients were followed up for at least 1 year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACEs
cardiac death, hospitalization for heart failure, target vessel revascularization，non-fatal MI
Measured: 12 months
Secondary outcomes (4)
cardiac death
All cause deaths will be considered cardiac unless a definite noncardiac cause can be established.
Measured: 12 months
hospitalization for heart failure
Hospitalization for heart failure was defined as admission because of new or deteriorating signs and symptoms of heart failure combined with the findings of noninvasive imaging or elevated B-type natriuretic peptide(BNP) and/or N-terminal pro-BNP concentration, and a discharge diagnosis of congestive heart failure.
Measured: 12 months
target lesion revascularization
The following 3 conditions need to be met at the same time:
- The new stenosis that developed within previously treated coronary segments and within 5 mm of their borders;
- The new stenosis resulted in the vessel μQFR ≤ 0.80;
- The patient subsequently underwent repeat PCI or coronary artery bypass grafting (CABG).
Measured: 12 months
Repeated myocardial infarction
Repeated myocardial infarction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start20 Dec 2022
- Primary completion20 Dec 2023
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- Retrospective
- Enrolment
- 2,663 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muwei Li, MD, Study chair, Fuwai central China cardiovascular hospotial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653765
- Sponsor's protocol ID
- HenanICE202201
- Acronym
- EARLYMYOAMR
- Status last verified
- Mar 2025
- First submitted
- 4 Nov 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The personal information of a large number of patients is involved. IPD is not provided to protect the privacy of participants.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of the Angio-based Microvascular Resistance Use One Single Angiographic View Measured After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT05653765
- Acronym / sponsor ID
- EARLYMYOAMR / HenanICE202201
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,663 participants (actual)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 16 Dec 2022 (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 goal of this observational study is to learn about in STEMI with Primary PCI Patients. The main questions it aims to answer are:
- To determine the value of AMR in predicting the long-term clinical prognosis of patients with STEMI after PPCI, and to find the best cut-off value.
- Analyze the factors of PPCI affecting AMR and explore the effective measures of PPCI microcirculation protection.
Radiographic images of STEMI receiving primary PCI treatment in several chest pain centers in China will be included. The last image of the infarct-related vessel will be used as a target to calculate its AMR. The relationship between AMR and long-term clinical prognosis was analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diagnostic cohort/derivation cohort | – | –The diagnostic/derivation cohort included STEMI patients who underwent PCI within 12 hours and CMR. The optimal AMR cutoff value for diagnosing CMD using CMR was determined by analyzing ROC curves. |
| prognostic cohort/validation cohort | – | –The prognostic cohort enrolled STEMI patients who underwent PPCI within 12 hours. All patients were followed up for at least 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent PPCI due to STEMI in several chest pain centers in China from January 1, 2012 to October 1, 2022
Key inclusion criteria (3 listed)
- Aged 18 or older
- Type 1 myocardial infarction
- Receive PPCI
Key exclusion criteria (9 listed)
- Failed to identify culprit vessels.
- Structural heart disease with moderate to severe aortic valve or mitral regurgitation and or stenosis that may affect cardiac function
- Dialysis patients with severe renal insufficiency
- Severe and uncontrollable arrhythmia
- Complicated with dilated cardiomyopathy
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
MACEs
Time frame: 12 months
cardiac death, hospitalization for heart failure, target vessel revascularization，non-fatal MI
4 secondary outcomes
cardiac death
Time frame: 12 months
hospitalization for heart failure
Time frame: 12 months
target lesion revascularization
Time frame: 12 months
Repeated myocardial infarction
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No. The personal information of a large number of patients is involved. IPD is not provided to protect the privacy of participants.
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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.
Muwei Li, MD study chair
Fuwai central China cardiovascular hospotial
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and ST Elevation Myocardial Infarction, run by Henan Institute of Cardiovascular Epidemiology at 5 sites 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACEs (time frame: 12 months). 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 17 Mar 2025.