Clinical trial NCT06118450: Clinical Trial for Evaluating the Effectiveness and Safety of Online caIMR in STEMI Patients
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Microvascular Coronary Artery Disease
STEMI
Keywords: STEMI
caIMR
coronary microvascular disease
Lead sponsor: The Affiliated Hospital of Xuzhou Medical University
Sponsor class: OTHER
Collaborators: name: RainMed Medical Group
First posted: 2023-11-07
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Aged between 18 and 80, regardless of gender. Initially diagnosed as STEMI and underwent primary PCI.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major Adverse Cardiovascular Events (MACE )
timeFrame: 12 months
Secondary outcomes:
measure: MACE
timeFrame: 1 month; 6months
measure: Outcome events for each category
timeFrame: 12 months
measure: Stroke
timeFrame: 12 months
measure: Malignant arrhythmia
timeFrame: 12 months
measure: Target vessel failure (TVF)
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Luhe Hospital.Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
city: Lianyungang
country: China
facility: The First People'S Hospital of Lianyungang
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: General Hospital of Xuzhou Mining Group
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou First People's Hospital
state: Jiangsu
Study officials:
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