STEMI Clinical Trial
— FlashIVOfficial 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)
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Hospital of Xuzhou Medical University | RainMed Medical |
China,
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* Note: There are 18 references in all — Click here to view all references
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 |
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