An observational study in Microvascular Coronary Artery Disease and STEMI, sponsored by The Affiliated Hospital of Xuzhou Medical University. Recruiting at 8 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-08.
Sponsored by The Affiliated Hospital of Xuzhou Medical University · Observational
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 335 is close to the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →The Affiliated Hospital of Xuzhou Medical University is the lead sponsor of 66 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Aged between 18 and 80, regardless of gender. Initially diagnosed as STEMI and underwent primary PCI.
Exclusion Criteria:
caIMR≥25
Other: Non-intervention
caIMR\<25
Other: Non-intervention
non-intervention
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.
Time frame: 12 months
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.
Time frame: 1 month; 6months
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.
Time frame: 12 months
Stroke
incidence rate
Time frame: 12 months
Malignant arrhythmia
incidence rate
Time frame: 12 months
Target vessel failure (TVF)
Rate of TVF. TVF was defined as a combined outcome, consisting of revascularization, infarction and death for target vessel
Time frame: 12 months
Plan to share: Undecided
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The Affiliated Hospital of Xuzhou Medical University