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

STEMI Clinical Trial

— FlashIV  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06118450
• Other study ID #: XYFY2023-QL152-02
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: November 2023
• Source: The Affiliated Hospital of Xuzhou Medical University
• Contact: Lu Yuan
• Phone: 86-13952110901
• Email: luyuan329[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 335
• Est. completion date: May 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Microvascular Coronary Artery Disease
• ST Elevation Myocardial Infarction
• STEMI

Intervention

Other:
• Non-intervention
non-intervention

Locations

Country	Name	City	State
China	Beijing Luhe Hospital.Capital Medical University	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Huai'an First People's Hospital	Huai'an	Jiangsu
China	The First People'S Hospital of Lianyungang	Lianyungang	Jiangsu
China	General Hospital of Xuzhou Mining Group	Xuzhou	Jiangsu
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	Xuzhou First People's Hospital	Xuzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The Affiliated Hospital of Xuzhou Medical University	RainMed Medical

Country where clinical trial is conducted

China, 

References & Publications (18)

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events (MACE )	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	MACE	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
Secondary	Outcome events for each category	Rate of cardiac death, rate of myocardial reinfarction, rate of readmission for heart failure, and rate of unplanned readmission for ischemia.	12 months
Secondary	Stroke	incidence rate	12 months
Secondary	Malignant arrhythmia	incidence rate	12 months
Secondary	Target vessel failure (TVF)	Rate of TVF. TVF was defined as a combined outcome, consisting of revascularization, infarction and death for target vessel	12 months