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Acute ST-segment Elevation Myocardial InfarctionNCT04628377

Prognostic Implication of Angiography-Derived IMR in STEMI Patients

An observational study of Acute ST-segment Elevation Myocardial Infarction, run by Samsung Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of STEMI patients. Previous study presented that index of microcirculatory resistance (IMR) in culprit vessel of STEMI patients showed significant association with the risk of cardiac death or heart failure… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Angiography-drived Index of Microcirculatory Resistance
Type of treatment
Medical device
How many people
333 participants
Where
No sites listed yet
Study dates
26 May 2003to 1 Apr 2023
How long will I take part?
10 Years
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Diagnostic Accuracy Cohort 31 STEMI patients who underwent IMR measurement in culprit vessel. Prognosis Cohort 309 patients with available angiograms and who were suitable for angiographic FFR and IMR measurement and have 10 years follow-up data.

Who may be able to join

  • STEMI patients who were successfully revascularized for culprit vessel
  • analyzable angiograms at the index procedure

Who cannot join

  • Previous coronary artery bypass grafting
  • Coronary bypass graft as culprit vessel
  • Patients with unclear culprit vessel
  • limited image quality of coronary angiography
  • Insufficient angiographic project for TIMI frame count
  • Severe tortuosity of culprit vessel
  • No optimal projection for reconstruction

About this study

Official title: Prognostic Implication of Angiography-Derived Index of Microcirculatory Resistance in Successfully Reperfused STEMI Patients

Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of STEMI patients. Previous study presented that index of microcirculatory resistance (IMR) in culprit vessel of STEMI patients showed significant association with the risk of cardiac death or heart failure admission. Recent technical development enabled angiographic derivation of IMR without pressure wire, hyperemic agents, or theromdilution method. In this regard, the current study will evaluate prognostic implication of angiography-derived IMR in STEMI patients who were successfully revascularized.

Read the detailed description

Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of STEMI patients. Previous study presented that index of microcirculatory resistance (IMR) in culprit vessel of STEMI patients showed significant association with the risk of cardiac death or heart failure admission. Recent technical development enabled angiographic derivation of IMR without pressure wire, hyperemic agents, or theromdilution method. In this regard, the current study will evaluate prognostic implication of angiography-derived IMR in STEMI patients who were successfully revascularized.

The study cohorts consist with 2 separate cohort: first, diagnostic accuracy cohort, which will evaluate diagnostic accuracy of angiography-derived IMR for invasive IMR. For this, 31 patients with culprit vessel IMR measurement at the time of primary PCI will be evaluated. The patients cohort is the subgroup of previous registry (NCT02186093). Second, prognosis cohort, in which angiography-derived IMR will be measured in the culprit vessel after successful revascularization. Those patients have follow-up data after 10 years from index procedure. This cohort is STEMI subgroup derived from Institutional registry of Samsung Medical Center, whose results were previously published (JACC Cardiovascular Intervention. 2019 Apr 8;12(7):607-620.) Among 490 STEMI patients from the overall study cohorts, 309 patients with available angiograms and who were suitable for angiographic FFR and IMR measurement will be analyzed. Primary clinical outcome will be cardiac death at 10 years from index procedure. Secondary outcome will be any myocardial infarction, ischemia-driven revascularization, definite or probable stent thrombosis, congestive heart failure admission at 10 years from index procedure.

Being tested
Angiography-drived Index of Microcirculatory Resistance
Keywords
STEMI, Index of microcirculatory resistance, Quantitative flow ratio, Fractional flow reserve, Prognosis, Angiography-derived IMR
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.

  • Angiography-drived Index of Microcirculatory ResistanceDevice

    Also called Angiography-derived IMR

    From coronary angiographic images, angiography-derived IMR will be calculated based on mathematical calculation.

    Angiography-derived IMR = (hyperemic Pa x angiography-derived FFR) x (vessel length / {K x V diastole}).

    Hyperemic Pa will be estimated from resting Pa according to prespecified equation.

Study groups in NCT04628377
Study groupRoleWhat they receive
Diagnostic Accuracy CohortPatients are subgroup of previously published study (JACC Cardiovascular Intervention 2020;13:1155-67), which evaluated invasive physiologic indices from culprit and non-culprit vessels of acute myocardial infarction patients. From the study cohort, 31 STEMI patients who underwent IMR measurement in culprit vessel after successful revascularization will be analyzed. In these patients, diagnostic accuracy of angiography-derived IMR will be compared with invasive IMR.
Receives: Device: Angiography-drived Index of Microcirculatory Resistance
Prognosis CohortPrognosis cohort, in which angiography-derived IMR will be measured in the culprit vessel after successful revascularization. Those patients have follow-up data after 10 years from index procedure. This cohort is STEMI subgroup derived from Institutional registry of Samsung Medical Center, whose results were previously published (JACC Cardiovascular Intervention. 2019 Apr 8;12(7):607-620.) Among 490 STEMI patients from the overall study cohorts, 309 patients with available angiograms and who were suitable for angiographic FFR and IMR measurement will be analyzed. Primary clinical outcome will be cardiac death at 10 years from index procedure. Secondary outcome will be any myocardial infarction, ischemia-driven revascularization, definite or probable stent thrombosis, congestive heart failure admission at 10 years from index procedure.
Receives: Device: Angiography-drived Index of Microcirculatory Resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accuracy

    Diagnostic accuracy of angiography-derived IMR to predict invasive IMR

    Measured: at the index procedure

  2. Cardiac death or heart failure admission

    Cardiac death or heart failure admission

    Measured: at 10 years from index procedure

Secondary outcomes (8)

  1. Any myocardial infarction

    Any myocardial infarction

    Measured: at 10 years from index procedure

  2. Ischemia-driven revascularization

    Ischemia-driven revascularization

    Measured: at 10 years from index procedure

  3. Stent thrombosis

    Definite or probable stent thrombosis according to ARC definition

    Measured: at 10 years from index procedure

  4. Congestive heart failure admission

    Admission for congestive heart failure

    Measured: at 10 years from index procedure

  5. Major adverse cardiac events

    a composite of cardiac death, any myocardial infarction, ischemia-driven revascularization, definite or probable stent thrombosis, or congestive heart failure admission

    Measured: at 10 years from index procedure

  6. Cardiac death

    Cardiac death

    Measured: at 10 years from index procedure

  7. All-cause death

    All-cause death

    Measured: at 10 years from index procedure

  8. Heart failure admission

    Heart failure admission

    Measured: at 10 years from index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2020
  2. Study start26 May 2003
  3. Primary completion1 Mar 2023
  4. Study completion1 Apr 2023

Resources

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
Case-control
Time perspective
Prospective
Enrolment
333 participants (actual)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04628377
Sponsor's protocol ID
NCTSTEMI2575
Status last verified
Apr 2023
First submitted
8 Nov 2020
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Anonymized study data can be shared upon reasonable proposition. Principle investigator will review the request and decide whether the study data will be shared.

Publications

  • Choi KH, Dai N, Li Y, Kim J, Shin D, Lee SH, Joh HS, Kim HK, Jeon KH, Ha SJ, Kim SM, Jang MJ, Park TK, Yang JH, Song YB, Hahn JY, Doh JH, Shin ES, Choi SH, Gwon HC, Lee JM. Functional Coronary Angiography-Derived Index of Microcirculatory Resistance in Patients With ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2021 Aug 9;14(15):1670-1684. doi: 10.1016/j.jcin.2021.05.027.

    PubMed 34353599

Questions about this trial

What is this clinical trial studying?

An observational study of Acute ST-segment Elevation Myocardial Infarction, run by Samsung Medical Center.

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: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Diagnostic accuracy (time frame: at the index procedure). The study lists 2 primary outcomes in all. 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 NCT04628377, 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 12 Apr 2023.

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