An interventional study of RIPC in Coronary Artery Disease, sponsored by Henan Institute of Cardiovascular Epidemiology. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-07.
Sponsored by Henan Institute of Cardiovascular Epidemiology · Not applicable, Interventional, and Other
Drug-coated balloon is being used more and more widely for the advantage of intervention without implantation.
But the balloon needs to be released long enough to be effective. Prolonged balloon dilation resulting in the cessation of blood flow in the distal vessels, especially large vessels, may result in severe ischemia in the patient.
RIPC can enhance patients' tolerance to ischemic events, so we believe that RIPC application before the use of drug balloon for PCI can improve patients' ischemic symptoms, thus increasing the release time of drug balloon and improving the effect.
Some patients receiving PCI cannot tolerate the symptoms of myocardial ischemia caused by the release of the drug balloon for a long time and even lead to the occurrence of adverse events.RIPC was found to improve tolerance to myocardial ischemia in patients.
At the same time, it can open collateral circulation and improve the tolerance of myocardial ischemia in patients.Therefore, this study designed a parallel control group. The experimental group was treated with RIPC before PCI, while the control group was not treated before PCI.
The operator does not know whether the patient has undergone RIPC or not, and the operator decides the time of drug balloon release according to the symptoms of the patient during the operation.Angiography was performed at 6 months, and QCA was used to determine late lumen loss at 1 year.The 1-year incidence of target lesion failure events was assessed.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 430 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Henan Institute of Cardiovascular Epidemiology is the lead sponsor of 29 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
40 minutes before PCI by the nurse to the patient RIPC operation (RIPC is delivered with a standard blood pressure cuff placed on the upper thigh. The cuffs are inflated to 200 mm Hg and keep inflated for 5 minutes,Then deflated to 0 mmHg and keep uninflated for 5 minutes, This cycle is repeated four times), and then do regular PCI operation
Other: RIPC
A standard cuff is placed on the patient's thigh by the nurse 40 minutes before PCI but it is not inflated. PCI is performed 40 minutes later
RIPC is delivered with a standard blood pressure cuff placed on the upper thigh. The cuffs are inflated to 200 mm Hg and keep inflated for 5 minutes,Then deflated to 0 mmHg and keep uninflated for 5 minutes, This cycle is repeated four times
TLF
TLF, a composite of cardiac death, target vessel-related myocardial infarction (MI; not clearly attributed to a nontarget vessel and excluding periprocedural MI), or clinically indicated target lesion revascularization (TLR)
Time frame: 12 months
Late lumen loss of target vessel（mm）
Late Lumen Loss of target vessel（mm） by Quantitative Coronary Angiography (QCA).
Time frame: 6 months
DCB expansion time
We hypothesis/speculated that the RIPC group had better ischemia tolerance, so the balloon dilation time was longer than the control group. But the total time for all patients is less than 120 seconds
Time frame: less than 120 seconds (On the 1 day of PCI)
Plan to share: No — After the results are published, researchers can obtain IPD from the responsible person on reasonable request
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Henan Institute of Cardiovascular Epidemiology