Clinical Trial for Evaluating the Effectiveness and Safety of Online caIMR in STEMI Patients (FlashIV)

November 5, 2023 updated by: The Affiliated Hospital of Xuzhou Medical University

A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Online Coronary Angiography-Derived Index of Microcirculatory Resistance in STEMI Patients (Flash IV)

Despite the success of restoration of epicardial blood flow by the primary percutaneous coronary intervention (PPCI), approximately a half of patients with ST-segment elevation myocardial infarction (STEMI) have failed myocardial reperfusion, as reflected by microvascular obstruction (MVO) and intramyocardial haemorrhage (IMH). The coronary angiography-derived index of microvascular resistance (caIMR) is a brand new method for assessing coronary microcirculation in ischemia and no obstructive coronary artery disease (INOCA). In this trial, the investigators aim to verify the safety and effectiveness of caIMR in STEMI who underwent primary PCI. The investigators will immediately measure the caIMR of patients who successfully underwent pPCI, and combine the caIMR with the long-term prognosis, to verify the prognostic performance of caIMR.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Despite the success of restoration of epicardial blood flow by the primary percutaneous coronary intervention (PPCI), approximately a half of patients with ST-segment elevation myocardial infarction (STEMI) have failed myocardial reperfusion, as reflected by microvascular obstruction (MVO) and intramyocardial haemorrhage (IMH). There are many defects in the current measurement technology, such as non-timely, long measurement time, high price, potential risk of gadolinium contrast agent.

The index of microcirculatory resistance (IMR) is a readily available, wire-based approach for assessing microvascular dysfunction immediately post-stenting for STEMI. The parameter has been used to characterize MVO, was associated with infarct size, and subsequent cardiac death and heart failure. However, the application of IMR in clinical practice remains limited, primarily due to the requirement of a pressure-temperature sensor wire and hyperaemic agents, which add complexity and time.

The development of functional coronary angiography has enabled the estimation of IMR based on angiography alone. The coronary angiography-derived index of microvascular resistance (caIMR) has shown good diagnostic accuracy compared with wire-based invasive IMR. This simple alternative index showed an association with extent of MVO and was of prognostic importance. In this trial, the investigators aim to verify the safety and effectiveness of caIMR in STEMI who underwent primary PCI. The investigators will immediately measure the caIMR of patients who successfully underwent pPCI, and combine the caIMR with the long-term prognosis, to verify the prognostic performance of caIMR.

Study Type

Observational

Enrollment (Estimated)

335

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Not yet recruiting
        • Peking University First Hospital
        • Contact:
          • Li Jianping, PHD
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Luhe Hospital.Capital Medical University
        • Contact:
          • Guangyao Zhai
    • Jiangsu
      • Huai'an, Jiangsu, China
        • Not yet recruiting
        • Huai'an First People's Hospital
        • Contact:
          • Zhang Xiwen
      • Lianyungang, Jiangsu, China
        • Not yet recruiting
        • The First People's Hospital of Lianyungang
        • Contact:
          • Yin Delu
      • Xuzhou, Jiangsu, China, 221002
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
          • Lu yuan
          • Phone Number: 86-13952110901
      • Xuzhou, Jiangsu, China
        • Not yet recruiting
        • General Hospital of Xuzhou Mining Group
        • Contact:
          • Qi chunmei
      • Xuzhou, Jiangsu, China
        • Not yet recruiting
        • Xuzhou Central Hospital
        • Contact:
          • Li Zhenyong
      • Xuzhou, Jiangsu, China
        • Not yet recruiting
        • Xuzhou First People's Hospital
        • Contact:
          • Wang Xiangzhi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Aged between 18 and 80, regardless of gender. Initially diagnosed as STEMI and underwent primary PCI.

Description

Inclusion Criteria:

  • Aged between 18 and 80, regardless of gender;
  • Initially diagnosed as STEMI and underwent primary PCI;
  • Voluntarily participated in this trial and signed the informed consent form.

Exclusion Criteria:

  • Coronary angiography shows that PCI is not suitable;
  • Past history of coronary artery bypass grafting (CABG);
  • Past history of heart failure;
  • Past history of myocardial infarction;
  • Primary or secondary cardiomyopathy or heart valve disease;
  • Patients with renal insufficiency (eGFR<30ml/min (1.73m^2)) or patients undergoing dialysis;
  • Cardiogenic shock
  • Persistent left or right coronary ostium lesion after target vessel PCI;
  • Immediate effect of target vessel PCI is unsatisfactory [such as thrombolysis in myocardial infarction (TIMI) flow < grade 2, dissection that restricted blood flow, side branch occlusion (diameter>1.5mm), exist distal embolism or angiographically visible thrombus];
  • Target vessel exist coronary fistula or myocardial bridge (lumen constriction >50%);
  • The target vessel cannot clearly expose the lesion in two positions with an included angle ≥ 30 degrees;
  • Severe systemic infection
  • Patients with malignant wasting disease, with an estimated survival of less than 1 year;
  • The subject is participating in another clinical researches, and the primary endpoint has not been reached;
  • The investigator believes that the subject has other conditions that are not suitable for clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
high caIMR
caIMR≥25
Other: Non-intervention
non-intervention
low caIMR
caIMR<25
Other: Non-intervention
non-intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events (MACE )
Time Frame: 12 months
Rate of MACE. MACE was defined as a composite endpoint of cardiac death, myocardial reinfarction, readmission for heart failure, and unplanned readmission for ischemia.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke
Time Frame: 12 months
incidence rate
12 months
Malignant arrhythmia
Time Frame: 12 months
incidence rate
12 months
MACE
Time Frame: 1 month; 6months
Rate of MACE. MACE was defined as a composite outcome of cardiac death, myocardial reinfarction, readmission for heart failure, and unplanned readmission for ischemia.
1 month; 6months
Outcome events for each category
Time Frame: 12 months
Rate of cardiac death, rate of myocardial reinfarction, rate of readmission for heart failure, and rate of unplanned readmission for ischemia.
12 months
Target vessel failure (TVF)
Time Frame: 12 months
Rate of TVF. TVF was defined as a combined outcome, consisting of revascularization, infarction and death for target vessel
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Xuzhou Medical University

Collaborators

RainMed Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY2023-QL152-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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