search
Back to results

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

Primary Purpose

STEMI, Multi Vessel Coronary Artery Disease, Percutaneous Coronary Intervention

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
In-hospital staged PCI
Out-hospital staged PCI
Sponsored by
Xiamen Cardiovascular Hospital, Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures;
  • Established indication to PPCI according to the guidelines of American Heart Association and American College of Cardiology;
  • Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset) with MVD after successful revascularization of the culprit artery;
  • De novo coronary lesion,
  • TIMI Flow 3 ( Cases with TIMI flow 2 need to perform angiographic again in 24h ensured TIMI flow 3 for enrolling case )after revascularization of the culprit artery, residual stenosis ≤20% and no coronary dissection greater than or equal to type C leading to (threatening) vessel closure.
  • At least one non-culprit coronary stenosis ≥ 80% and accompanied by QFR ≤0.8 in a vessel with a lumen diameter ≥2.5;

Exclusion Criteria:

  • Age <18 yr and >80 yr;
  • Cardiac shock, multiple organ failure, cerebral hemorrhage, severe aortic stenosis and myocardial infarction complications(cardiac rupture, ventricular septal rupture and papillary muscle rupture);
  • Killip classification >3, cardiognic shock, shore-infarction of culprit artery after emergency PCI in 24 hours;
  • Previous documented allergic reaction to drug and device of this study;
  • Planned major surgery within 6 weeks in which impact DAPT;
  • Participation in another clinical study, interfering with this protocol Uncertain;
  • Life expectancy < 1 year;
  • Any condition likely to interfere with study processes including follow-up visits or increase of risk accessed by researcher.

Sites / Locations

  • Xiamen Cardiovascular Hospital Xiamen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

In-hospital staged PCI

Out-hospital staged PCI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

all-cause mortality
The difference in all-cause mortality will be calculated from 0 month to 12 months.

Secondary Outcome Measures

Major adverse cardiovascular and cerebrovascular events (MACE)
The difference in MACCE will be calculated from 1 month to 12 months.
Rate of Stroke
Rate of contrast-induced nephropathy（CIN）
Dosimetry calculation（The amount of X-ray exposure shown by the DSA）
The amount of X-ray exposure shown by the DSA

Full Information

First Posted
May 24, 2021
Last Updated
October 29, 2022
Sponsor
Xiamen Cardiovascular Hospital, Xiamen University
search

1. Study Identification

Unique Protocol Identification Number
NCT04918030
Brief Title
STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease（STAGED）
Official Title
STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease （STAGED）
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xiamen Cardiovascular Hospital, Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI, Multi Vessel Coronary Artery Disease, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In-hospital staged PCI
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Out-hospital staged PCI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
In-hospital staged PCI
Other Intervention Name(s)
Percutaneous coronary intervention
Intervention Description
After revascularization of the culprit lesion, all significant non-culprit vessel will be complete revascularzed during index the index procedure (7±3 day).
Intervention Type
Procedure
Intervention Name(s)
Out-hospital staged PCI
Other Intervention Name(s)
Percutaneous coronary intervention
Intervention Description
During the index procedure, patients will have treated with primary PCI the culprit lesion only. Patients will be hospitalized again after 30±15 days to undergo PCI of the other significant coronary lesions.
Primary Outcome Measure Information:
Title
all-cause mortality
Description
The difference in all-cause mortality will be calculated from 0 month to 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Major adverse cardiovascular and cerebrovascular events (MACE)
Description
The difference in MACCE will be calculated from 1 month to 12 months.
Time Frame
12 months
Title
Rate of Stroke
Time Frame
12 months
Title
Rate of contrast-induced nephropathy（CIN）
Time Frame
12 months
Title
Dosimetry calculation（The amount of X-ray exposure shown by the DSA）
Description
The amount of X-ray exposure shown by the DSA
Time Frame
Immediately after PCI

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of informed consent prior to any study specific procedures; Established indication to PPCI according to the guidelines of American Heart Association and American College of Cardiology; Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset) with MVD after successful revascularization of the culprit artery; De novo coronary lesion, TIMI Flow 3 ( Cases with TIMI flow 2 need to perform angiographic again in 24h ensured TIMI flow 3 for enrolling case )after revascularization of the culprit artery, residual stenosis ≤20% and no coronary dissection greater than or equal to type C leading to (threatening) vessel closure. At least one non-culprit coronary stenosis ≥ 80% and accompanied by QFR ≤0.8 in a vessel with a lumen diameter ≥2.5; Exclusion Criteria: Age <18 yr and >80 yr; Cardiac shock, multiple organ failure, cerebral hemorrhage, severe aortic stenosis and myocardial infarction complications(cardiac rupture, ventricular septal rupture and papillary muscle rupture); Killip classification >3, cardiognic shock, shore-infarction of culprit artery after emergency PCI in 24 hours; Previous documented allergic reaction to drug and device of this study; Planned major surgery within 6 weeks in which impact DAPT; Participation in another clinical study, interfering with this protocol Uncertain; Life expectancy < 1 year; Any condition likely to interfere with study processes including follow-up visits or increase of risk accessed by researcher.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Chen, Dr
Phone
18033997788
Email
Seanchenx@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Wang, Dr
Organizational Affiliation
Clinical Trial Center of Xiamen Cardiovascular Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiamen Cardiovascular Hospital Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Wang, Ph.D
Email
wy@medmail.com.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs