Other Clinical Trial - STaged Interventional Strategies for Acute

Status Recruiting

Clinical Trial Summary

An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD Objectives: The present study aimed to investigate the difference in all-cause mortality after in-hospital staged PCI versus out-hospital staged PCI for ST-segment elevated myocardial infarction （STEMI）patients with multi-vessel Disease（MVD） Background: In primary percutaneous coronary intervention for STEMI with MVD, complete revascularization has proved to reduce the risk of cardiovascular death and myocardial infarction. However, a strategy of nonculprit-vessel PCI with the goal of complete revascularization still not to be confirmed. Compare with in-hospital staged PCI, out-hospital PCI as a strategy of nonculprit-vessel PCI for STEMI patients with MVD might have be beneficial results.

Clinical Trial Description

A total of 1700 subjects with STEMI who met inclusion criteria and do not have any exclusion criterion will be randomized to in-hospital staged PCI group and out-hospital staged PCI group. After successful percutaneous coronary intervention for culprit lesion, all non-culprit vessel with significant lesion defined at least 80% diameter stenosis by visual estimation and accompanied by a QFR measurement of less than or equal to 0.80 will be performed complete revascularization. 1. Patients randomized to in-hospital staged PCI will have treated during the index procedure (7±3 days), after revascularization of the culprit lesion, all significant non-culprit coronary lesions. 2. Patients randomized to out-hospital staged complete revascularization will have treated during the index procedure only the culprit lesion, and they will be hospitalized in 30±15 days for complete revascularization of all significant non-culprit coronary lesions. ;

Study Design

Related Conditions & MeSH terms

Coronary Artery Disease
Infarction
Multi Vessel Coronary Artery Disease
Myocardial Infarction
Percutaneous Coronary Intervention
ST Elevation Myocardial Infarction
STEMI

Clinical Trial Details

NCT number	NCT04918030
Study type	Interventional
Source	Xiamen Cardiovascular Hospital, Xiamen University
Contact	Xiang Chen, Dr
Phone	18033997788
Email	Seanchenx@126.com
Status	Recruiting
Phase	N/A
Start date	February 11, 2021
Completion date	May 1, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease（STAGED）

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms