ST Elevation (STEMI) Myocardial InfarctionIMCOMENCT06759532
Impact of Persistent Microvascular Obstruction by Cardiac Magnetic Resonance on Prognosis for ST-segment Elevation Myocardial Infarction
An observational study of ST Elevation (STEMI) Myocardial Infarction, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The aims of the study were to evaluate the predictive value of persistent microvascular obstruction (MVO) by cardiac magnetic resonance for main adverse cardiac events in ST-segment elevation myocardial infarction patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ST Elevation (STEMI) Myocardial Infarction
- How many people
- 344 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 20 Oct 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients in this study were diagnosis as STEMI, and were plan to undergo primary percutaneous coronary intervention and were plan to underwent cardiac magnetic resonance at 7 days and 6 months after primary percutaneous coronary intervention . The patients were divided into three groups according to the presence of absence of MVO at the first cardiac magnetic resonance and second cardiac magnetic resonance.
Who may be able to join
- ST-segment elevation myocardial infarction undewent primary percutaneous coronary intervention
Who cannot join
- contraindications for cardiac magnetic resonance
- severe heart failure
- previous myocardial infarction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Role of Persistent Microvascular Obstruction by Cardiac Magnetic Resonance for ST-segment Elevation Myocardial Infarction
The aims of the study were to evaluate the predictive value of persistent microvascular obstruction (MVO) by cardiac magnetic resonance for main adverse cardiac events in ST-segment elevation myocardial infarction patients.
MVO in the acute phase of myocardial infarction has been considered to be strong predictor of a poor prognosis. We plan to explore the relationship between persistent MVO and the long-term prognosis of patients with STEMI. We made hypothesis that patients with persistent MVO have a poor prognosis.
- Keywords
- Microvascular occlusion;, ST-segment elevation myocardial infarction, Prognosis
- Medical subject headings
- ST Elevation Myocardial Infarction, 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 |
|---|---|---|
| Without MVO group | STEMI patients without MVO both in the acutephase and chronic phase of myocardial inarction | |
| with transient MVO group | STEMI patients with MVO only in the acutephase of myocardial inarction | |
| with persietent MVO group | STEMI patients without MVO both in the acutephase and chronic phase of myocardial inarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main aderverse cardiac events
Composite endpoint of all-cause death, readmission due to heart failure, recurrent myocardial infarction, and unexpected vascularization.
Measured: 5 years after myocardiac infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Apr 2017
- Primary completion20 Jul 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ST Elevation (STEMI) Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian geng, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759532
- Sponsor's protocol ID
- Persistent MVO on prognosis
- Other IDs
- Z-2017-26-2202-2
- Acronym
- IMCOME
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Symons R, Pontone G, Schwitter J, Francone M, Iglesias JF, Barison A, Zalewski J, de Luca L, Degrauwe S, Claus P, Guglielmo M, Nessler J, Carbone I, Ferro G, Durak M, Magistrelli P, Lo Presti A, Aquaro GD, Eeckhout E, Roguelov C, Andreini D, Vogt P, Guaricci AI, Mushtaq S, Lorenzoni V, Muller O, Desmet W, Agati L, Janssens S, Bogaert J, Masci PG. Long-Term Incremental Prognostic Value of Cardiovascular Magnetic Resonance After ST-Segment Elevation Myocardial Infarction: A Study of the Collaborative Registry on CMR in STEMI. JACC Cardiovasc Imaging. 2018 Jun;11(6):813-825. doi: 10.1016/j.jcmg.2017.05.023. Epub 2017 Aug 16.
PubMed 28823746Bodi V, Gavara J, Lopez-Lereu MP, Monmeneu JV, de Dios E, Perez-Sole N, Bonanad C, Marcos-Garces V, Canoves J, Minana G, Nunez J, Moratal D, Chorro FJ, Rodriguez-Palomares JF, Freixa A, Borras R, Ortiz-Perez JT, Rios-Navarro C. Impact of Persistent Microvascular Obstruction Late After STEMI on Adverse LV Remodeling: A CMR Study. JACC Cardiovasc Imaging. 2023 Jul;16(7):919-930. doi: 10.1016/j.jcmg.2023.01.021. Epub 2023 Apr 12.
PubMed 37052556Lechner I, Reindl M, Stiermaier T, Tiller C, Holzknecht M, Oberhollenzer F, von der Emde S, Mayr A, Feistritzer HJ, Carberry J, Carrick D, Bauer A, Thiele H, Berry C, Eitel I, Metzler B, Reinstadler SJ. Clinical Outcomes Associated With Various Microvascular Injury Patterns Identified by CMR After STEMI. J Am Coll Cardiol. 2024 May 28;83(21):2052-2062. doi: 10.1016/j.jacc.2024.03.408.
PubMed 38777509Orn S, Manhenke C, Greve OJ, Larsen AI, Bonarjee VV, Edvardsen T, Dickstein K. Microvascular obstruction is a major determinant of infarct healing and subsequent left ventricular remodelling following primary percutaneous coronary intervention. Eur Heart J. 2009 Aug;30(16):1978-85. doi: 10.1093/eurheartj/ehp219. Epub 2009 Jun 6.
PubMed 19502624Bodi V, Sanchis J, Lopez-Lereu MP, Nunez J, Sanz R, Palau P, Gomez C, Moratal D, Chorro FJ, Llacer A. Microvascular perfusion 1 week and 6 months after myocardial infarction by first-pass perfusion cardiovascular magnetic resonance imaging. Heart. 2006 Dec;92(12):1801-7. doi: 10.1136/hrt.2005.077305. Epub 2006 Jun 27.
PubMed 16803939Weir RA, Murphy CA, Petrie CJ, Martin TN, Balmain S, Clements S, Steedman T, Wagner GS, Dargie HJ, McMurray JJ. Microvascular obstruction remains a portent of adverse remodeling in optimally treated patients with left ventricular systolic dysfunction after acute myocardial infarction. Circ Cardiovasc Imaging. 2010 Jul;3(4):360-7. doi: 10.1161/CIRCIMAGING.109.897439. Epub 2010 Mar 26.
PubMed 20348438van Kranenburg M, Magro M, Thiele H, de Waha S, Eitel I, Cochet A, Cottin Y, Atar D, Buser P, Wu E, Lee D, Bodi V, Klug G, Metzler B, Delewi R, Bernhardt P, Rottbauer W, Boersma E, Zijlstra F, van Geuns RJ. Prognostic value of microvascular obstruction and infarct size, as measured by CMR in STEMI patients. JACC Cardiovasc Imaging. 2014 Sep;7(9):930-9. doi: 10.1016/j.jcmg.2014.05.010.
PubMed 25212799Rios-Navarro C, Marcos-Garces V, Bayes-Genis A, Husser O, Nunez J, Bodi V. Microvascular Obstruction in ST-Segment Elevation Myocardial Infarction: Looking Back to Move Forward. Focus on CMR. J Clin Med. 2019 Oct 28;8(11):1805. doi: 10.3390/jcm8111805.
PubMed 31661823
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Role of Persistent Microvascular Obstruction by Cardiac Magnetic Resonance for ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06759532
- Acronym / sponsor ID
- IMCOME / Persistent MVO on prognosis
- Keywords
- Microvascular occlusion;, ST-segment elevation myocardial infarction, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 6 Jan 2025 (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 aims of the study were to evaluate the predictive value of persistent microvascular obstruction (MVO) by cardiac magnetic resonance for main adverse cardiac events in ST-segment elevation myocardial infarction patients.
MVO in the acute phase of myocardial infarction has been considered to be strong predictor of a poor prognosis. We plan to explore the relationship between persistent MVO and the long-term prognosis of patients with STEMI. We made hypothesis that patients with persistent MVO have a poor prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Without MVO group | – | –STEMI patients without MVO both in the acutephase and chronic phase of myocardial inarction |
| with transient MVO group | – | –STEMI patients with MVO only in the acutephase of myocardial inarction |
| with persietent MVO group | – | –STEMI patients without MVO both in the acutephase and chronic phase of myocardial inarction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients in this study were diagnosis as STEMI, and were plan to undergo primary percutaneous coronary intervention and were plan to underwent cardiac magnetic resonance at 7 days and 6 months after primary percutaneous coronary intervention . The patients were divided into three groups according to the presence of absence of MVO at the first cardiac magnetic resonance and second cardiac magnetic resonance.
Key inclusion criteria (1 listed)
- ST-segment elevation myocardial infarction undewent primary percutaneous coronary intervention
Key exclusion criteria (3 listed)
- contraindications for cardiac magnetic resonance
- severe heart failure
- previous myocardial infarction.
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
Main aderverse cardiac events
Time frame: 5 years after myocardiac infarction
Composite endpoint of all-cause death, readmission due to heart failure, recurrent myocardial infarction, and unexpected vascularization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Results publication: PubMed 28823746Symons R, Pontone G, Schwitter J, Francone M, Iglesias JF, Barison A, Zalewski J, de Luca L, Degrauwe S, Claus P, Guglielmo M, Nessler J, Carbone I, Ferro G, Durak M, Magistrelli P, Lo Presti A, Aquaro GD, Eeckhout E, Roguelov C, Andreini D, Vogt P, Guaricci AI, Mushtaq S, Lorenzoni V, Muller O, Desmet W, Agati L, Janssens S, Bogaert J, Masci PG. Long-Term Incremental Prognostic Value of Cardiovascular Magnetic Resonance After ST-Segment Elevation Myocardial Infarction: A Study of the Collaborative Registry on CMR in STEMI. JACC Cardiovasc Imaging. 2018 Jun;11(6):813-825. doi: 10.1016/j.jcmg.2017.05.023. Epub 2017 Aug 16.
- Results publication: PubMed 37052556Bodi V, Gavara J, Lopez-Lereu MP, Monmeneu JV, de Dios E, Perez-Sole N, Bonanad C, Marcos-Garces V, Canoves J, Minana G, Nunez J, Moratal D, Chorro FJ, Rodriguez-Palomares JF, Freixa A, Borras R, Ortiz-Perez JT, Rios-Navarro C. Impact of Persistent Microvascular Obstruction Late After STEMI on Adverse LV Remodeling: A CMR Study. JACC Cardiovasc Imaging. 2023 Jul;16(7):919-930. doi: 10.1016/j.jcmg.2023.01.021. Epub 2023 Apr 12.
- Results publication: PubMed 38777509Lechner I, Reindl M, Stiermaier T, Tiller C, Holzknecht M, Oberhollenzer F, von der Emde S, Mayr A, Feistritzer HJ, Carberry J, Carrick D, Bauer A, Thiele H, Berry C, Eitel I, Metzler B, Reinstadler SJ. Clinical Outcomes Associated With Various Microvascular Injury Patterns Identified by CMR After STEMI. J Am Coll Cardiol. 2024 May 28;83(21):2052-2062. doi: 10.1016/j.jacc.2024.03.408.
- Results publication: PubMed 19502624Orn S, Manhenke C, Greve OJ, Larsen AI, Bonarjee VV, Edvardsen T, Dickstein K. Microvascular obstruction is a major determinant of infarct healing and subsequent left ventricular remodelling following primary percutaneous coronary intervention. Eur Heart J. 2009 Aug;30(16):1978-85. doi: 10.1093/eurheartj/ehp219. Epub 2009 Jun 6.
- Results publication: PubMed 16803939Bodi V, Sanchis J, Lopez-Lereu MP, Nunez J, Sanz R, Palau P, Gomez C, Moratal D, Chorro FJ, Llacer A. Microvascular perfusion 1 week and 6 months after myocardial infarction by first-pass perfusion cardiovascular magnetic resonance imaging. Heart. 2006 Dec;92(12):1801-7. doi: 10.1136/hrt.2005.077305. Epub 2006 Jun 27.
- Results publication: PubMed 20348438Weir RA, Murphy CA, Petrie CJ, Martin TN, Balmain S, Clements S, Steedman T, Wagner GS, Dargie HJ, McMurray JJ. Microvascular obstruction remains a portent of adverse remodeling in optimally treated patients with left ventricular systolic dysfunction after acute myocardial infarction. Circ Cardiovasc Imaging. 2010 Jul;3(4):360-7. doi: 10.1161/CIRCIMAGING.109.897439. Epub 2010 Mar 26.
- Results publication: PubMed 25212799van Kranenburg M, Magro M, Thiele H, de Waha S, Eitel I, Cochet A, Cottin Y, Atar D, Buser P, Wu E, Lee D, Bodi V, Klug G, Metzler B, Delewi R, Bernhardt P, Rottbauer W, Boersma E, Zijlstra F, van Geuns RJ. Prognostic value of microvascular obstruction and infarct size, as measured by CMR in STEMI patients. JACC Cardiovasc Imaging. 2014 Sep;7(9):930-9. doi: 10.1016/j.jcmg.2014.05.010.
- Results publication: PubMed 31661823Rios-Navarro C, Marcos-Garces V, Bayes-Genis A, Husser O, Nunez J, Bodi V. Microvascular Obstruction in ST-Segment Elevation Myocardial Infarction: Looking Back to Move Forward. Focus on CMR. J Clin Med. 2019 Oct 28;8(11):1805. doi: 10.3390/jcm8111805.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ST Elevation (STEMI) Myocardial Infarction, run by Chinese PLA General 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 1 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: finished, as of the sponsor's last update on 6 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Main aderverse cardiac events (time frame: 5 years after myocardiac 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 NCT06759532, which also lists 8 linked publications.
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 6 Jan 2025.