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NCT Number: NCT04628377

Prognostic Implication of Angiography-Derived IMR in 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiography-drived Index of Microcirculatory Resistance

Device

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 names: Angiography-derived IMR

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • RainMed Medical Group

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2023
Study completion
2023
First posted
Nov 13, 2020
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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