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Prognostic Implication of Angiography-Derived IMR in STEMI Patients

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ClinicalTrials.gov Identifier: NCT04628377
Recruitment Status : Active, not recruiting
First Posted : November 13, 2020
Last Update Posted : September 21, 2021
Sponsor:
Collaborator:
RainMed Medical
Information provided by (Responsible Party):
Joo Myung Lee, Samsung Medical Center

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment
Acute ST-segment Elevation Myocardial Infarction Device: Angiography-drived Index of Microcirculatory Resistance

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.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 333 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Prognostic Implication of Angiography-Derived Index of Microcirculatory Resistance in Successfully Reperfused STEMI Patients
Actual Study Start Date : May 26, 2003
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Diagnostic Accuracy Cohort
Patients 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.
 Device: Angiography-drived Index of Microcirculatory Resistance

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.

Other Name: Angiography-derived IMR
Prognosis Cohort
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.
 Device: Angiography-drived Index of Microcirculatory Resistance

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.

Other Name: Angiography-derived IMR


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: at the index procedure ]
    Diagnostic accuracy of angiography-derived IMR to predict invasive IMR

  2. Cardiac death or heart failure admission [ Time Frame: at 10 years from index procedure ]
    Cardiac death or heart failure admission


Secondary Outcome Measures :
  1. Any myocardial infarction [ Time Frame: at 10 years from index procedure ]
    Any myocardial infarction

  2. Ischemia-driven revascularization [ Time Frame: at 10 years from index procedure ]
    Ischemia-driven revascularization

  3. Stent thrombosis [ Time Frame: at 10 years from index procedure ]
    Definite or probable stent thrombosis according to ARC definition

  4. Congestive heart failure admission [ Time Frame: at 10 years from index procedure ]
    Admission for congestive heart failure

  5. Major adverse cardiac events [ Time Frame: at 10 years from index procedure ]
    a composite of cardiac death, any myocardial infarction, ischemia-driven revascularization, definite or probable stent thrombosis, or congestive heart failure admission

  6. Cardiac death [ Time Frame: at 10 years from index procedure ]
    Cardiac death

  7. All-cause death [ Time Frame: at 10 years from index procedure ]
    All-cause death

  8. Heart failure admission [ Time Frame: at 10 years from index procedure ]
    Heart failure admission


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628377


Sponsors and Collaborators
Samsung Medical Center
RainMed Medical
Investigators
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Principal Investigator: Joo Myung Lee, MD, MPH, PhD Samsung Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Joo Myung Lee, Assistant Professore, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04628377    
Other Study ID Numbers: NCTSTEMI2575
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymized study data can be shared upon reasonable proposition. Principle investigator will review the request and decide whether the study data will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joo Myung Lee, Samsung Medical Center:
STEMI
Index of microcirculatory resistance
Quantitative flow ratio
 Fractional flow reserve
Prognosis
Angiography-derived IMR
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases