Acute ST Segment Elevation Myocardial InfarctionNCT06435728
Predictive Value of Combining AccuIMR and AccuFFR in Patients With STEMI
An observational study of Acute ST Segment Elevation Myocardial Infarction and Prognosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
Patients with acute myocardial infarction were enrolled retrospectively. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were analyzed, and the relationship between FFR and IMR and the prognosis of patients with acute myocardial infarction was analyzed Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute ST Segment Elevation Myocardial Infarction, Prognosis
- What is being tested?
- AccuIMR and AccuFFR
- How many people
- 1,297 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 30 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with STEMI who underwent primary PCI and were hospitalized at Peking University Third Hospital between January 2017 and March 2022.
Who may be able to join
- Age of >18 years;
- Onset-to-treatment time of ≤12 h, meeting the diagnostic criteria for STEMI;
- underwent primary PCI within 12 h of symptom onset and achieved successful PCI in the culprit vessel;
- Availability of complete clinical data
Who cannot join
- severe tortuosity and overlap of the target vessel;
- poor-quality coronary angiography images;
- missing two coronary angiography images >25° apart
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of Combining Angio-Based Index of Microcirculatory Resistance and Fractional Flow Reserve in Patients With STEMI
Patients with acute myocardial infarction were enrolled retrospectively. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were analyzed, and the relationship between FFR and IMR and the prognosis of patients with acute myocardial infarction was analyzed
Read the detailed description
We retrospectively enrolled STEMI patients who underwent PCI in Peking University Third Hospital. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were obtained by analyzing the coronary angiography images. The prognosis of patients was obtained by searching inpatient and outpatient systems and telephone follow-up. The relationship between AccuFFR, AccuIMR and prognosis was statistically analyzed
- Being tested
- AccuIMR and AccuFFR
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuIMR and AccuFFRDiagnostic test
AccuFFR and AccuIMR were obtained by reviewing coronary angiography at the time of primary PCI
| Study group | Role | What they receive |
|---|---|---|
| STEMI | Patients with STEMI who underwent primary PCI and were hospitalized at Peking University Third Hospital between January 2017 and March 2022 Receives: Diagnostic Test: AccuIMR and AccuFFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
cardiovascular death, all-cause death, readmission for heart failure (HF), and recurrent coronary events
Measured: 3 years after myocardial infarction
Secondary outcomes (1)
recurrent coronary events
nonfatal myocardial infarction, unplanned PCI, and unplanned coronary artery bypass grafting
Measured: 3 years after myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Mar 2024
- Primary completion30 Apr 2024
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Retrospective
- Enrolment
- 1,297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Cui, Dorctor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435728
- Sponsor's protocol ID
- D2023173
- Status last verified
- May 2024
- First submitted
- 26 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Xie P, Hu Y, Zhou Y, Zhao W, Xu X, Zhu D, Mi L, Xiang J, Cui M. Predictive Value of Combining Angio-Based Index of Microcirculatory Resistance and Fractional Flow Reserve in Patients with STEMI. Can J Cardiol. 2025 Jul;41(7):1363-1371. doi: 10.1016/j.cjca.2025.02.003. Epub 2025 Feb 6.
PubMed 39922306
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Combining Angio-Based Index of Microcirculatory Resistance and Fractional Flow Reserve in Patients With STEMI
- ClinicalTrials.gov ID
- NCT06435728
- Acronym / sponsor ID
- D2023173
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,297 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 30 May 2024 (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.
Patients with acute myocardial infarction were enrolled retrospectively. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were analyzed, and the relationship between FFR and IMR and the prognosis of patients with acute myocardial infarction was analyzed
Detailed description
We retrospectively enrolled STEMI patients who underwent PCI in Peking University Third Hospital. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were obtained by analyzing the coronary angiography images. The prognosis of patients was obtained by searching inpatient and outpatient systems and telephone follow-up. The relationship between AccuFFR, AccuIMR and prognosis was statistically analyzed
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | Diagnostic Test: AccuIMR and AccuFFRPatients with STEMI who underwent primary PCI and were hospitalized at Peking University Third Hospital between January 2017 and March 2022 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with STEMI who underwent primary PCI and were hospitalized at Peking University Third Hospital between January 2017 and March 2022.
Key inclusion criteria (4 listed)
- Age of >18 years;
- Onset-to-treatment time of ≤12 h, meeting the diagnostic criteria for STEMI;
- underwent primary PCI within 12 h of symptom onset and achieved successful PCI in the culprit vessel;
- Availability of complete clinical data
Key exclusion criteria (3 listed)
- severe tortuosity and overlap of the target vessel;
- poor-quality coronary angiography images;
- missing two coronary angiography images >25° apart
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccuIMR and AccuFFRAccuFFR and AccuIMR were obtained by reviewing coronary angiography at the time of primary PCI | Diagnostic test | STEMI |
Primary outcome
MACE
Time frame: 3 years after myocardial infarction
cardiovascular death, all-cause death, readmission for heart failure (HF), and recurrent coronary events
1 secondary outcome
recurrent coronary events
Time frame: 3 years after myocardial infarction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Derived from this study: PubMed 39922306Li J, Xie P, Hu Y, Zhou Y, Zhao W, Xu X, Zhu D, Mi L, Xiang J, Cui M. Predictive Value of Combining Angio-Based Index of Microcirculatory Resistance and Fractional Flow Reserve in Patients with STEMI. Can J Cardiol. 2025 Jul;41(7):1363-1371. doi: 10.1016/j.cjca.2025.02.003. Epub 2025 Feb 6.
- Individual participant dataSharing planned: No
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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.
Ming Cui, Dorctor principal investigator
Peking University Third Hospital
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 Acute ST Segment Elevation Myocardial Infarction and Prognosis, run by Peking University Third 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 4 inclusion and 3 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 30 May 2024. 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?
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?
MACE (time frame: 3 years after myocardial infarction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06435728, which also lists 1 linked publication.
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 30 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.