Timing of Complete Revascularization in Patients With ST-segment Elevation Myocardial Infarction And Multivessel Disease

ST-elevation Myocardial Infarction Clinical Trial

— TERMINAL  

Official title:

Timing of Complete Revascularization in Patients With ST-segment Elevation Myocardial Infarction And Multivessel Disease-A Multi-center Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05231226
• Other study ID #: 2021-20
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2022
• Source: Beijing Anzhen Hospital
• Contact: Xiaotong Hou, MD,PhD
• Phone: 8610 64456631
• Email: xt.hou[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

At present, the two treatment strategies of opening non infarct related arteries (non IRA) simultaneously or by stages after emergency percutaneous coronary intervention (PCI) in patients with acute ST segment elevation myocardial infarction (STEMI) complicated with multi vessel disease (MVD) are still controversial. In our previous retrospective analysis, there was no significant difference between complete revascularization (CR) and staged CR at Anzhen Hospital in the cases of cardiac death, reinfarction, stroke, proportion of revascularization and hospitalization rate of heart failure.

Description:

The literature reports on the benefits of two CR strategies of opening non IRA simultaneously or by stages after IRA treatment in STEMI patients are inconsistent. This study intends to enroll 426 cases and divide into two groups to verify whether the occurrence of major cardiovascular adverse events (all-cause death, nonfatal myocardial infarction, ischemia driven revascularization and heart failure) in one year in immediately open non-IRA after successful emergency PCI of infarct related arteries in STEMI patients with MVD group is not inferior to staged (within 45 days) CR group. It can accumulate more evidence-based medical basis for the selection of better treatment schemes, so as to formulate optimized treatment schemes for clinic. To study when to open meaningful non IRA in acute STEMI complicated with MVD is of great guiding significance for CR after acute myocardial infarction. At the same time, it has important social significance and economic value for delaying or preventing cardiovascular events.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 426
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Onset of the spontaneous acute STEMI (24 hours).

2. The anatomical structure of coronary artery is suitable for complete revascularization by PCI.

3. It is suitable for PCI through radial artery or femoral artery.

4. Be able to fully identify Infarct-related artery(IRA).

5. In addition to IRA, in the vessels of lumen diameter is 2.25mm or more, but less than 4.5mm. there is at least one non IRA's stenosis more than 70% observed in both planes, or 50% ~ 69% stenosis and fractional flow reserve (FFR) or Quantitative Flow Ratio (QFR) measured value is 0.80 or less.

6. After IRA revascularization the thrombolysis in myocardial infarction (TIMI) blood flow is in grade 3.

7. The hemodynamics of patients after IRA revascularization is stable, that is, systolic blood pressure = 90mmHg, or blood pressure = 90mmHg after catecholamines, and there is no clinical manifestation of hypoperfusion.

8. Patient who has signed informed consent

Exclusion Criteria:

1. Cardiogenic shock which means a group of clinical syndromes leading to cardiac dysfunction caused by various reasons, which meet the following criteria: A: continuous hypotension, systolic blood pressure < 90mmHg or mean arterial pressure decreased from baseline = 30mmhg, more than 30min; B: cardiac index < 1.8l/min/m2, pulmonary congestion or elevated left ventricular filling pressure; c: Signs of organ perfusion damage (at least one): changes in mental state, wet and cold skin, oliguria, and increased serum lactic acid level.

2. The duration of cardiopulmonary resuscitation is more than 10 minutes.

3. Emergency coronary artery bypass grafting (CABG) is needed.

4. Previous coronary-artery bypass grafting surgery.

5. Hybrid revascularization is planned.

6. Coronary dissection.

7. Stent thrombosis.

8. In stent restenosis, definition: A: target vessel diameter stenosis = 50% at follow-up. b: The lumen loss at follow-up was larger than 50% of the net lumen gain after operation. c: The lumen diameter at follow-up and the minimum diameter loss measured immediately at stenting were 0.72 mm or more.

9. Acute myocardial infarction complicated with severe mechanical complications, defined as acute severe mitral regurgitation, ventricular septal perforation and cardiac free wall rupture / pericardial tamponade.

10. Severe renal failure (EGFR < 30ml / min) or dialysis treatment is required.

11. Chronic total occlusion of main coronary artery.

12. Complex bifurcation lesions requiring dual stent treatment.

13. Stenosis of Left main coronary artery= 50% or stenosis of left anterior descending coronary artery and circumflex coronary artery = 70%.

14. Coronary, cerebrovascular or peripheral revascularization is planned.

15. Cardiac surgery or other surgical treatment is planned.

16. Contraindications to double antibody therapy [aspirin and P2Y12 inhibitor (clopidogrel or ticagrelor) for 3 months.

17. pregnant woman.

18. Patient who has participated in other clinical trials.

19. Life expectancy < 1 year.

20. Patient who is not suitable for inclusion in the study according to the operator's judgment.

Related Conditions & MeSH terms

• Coronary Disease
• Infarction
• Multivessel Coronary Disease
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-elevation Myocardial Infarction

Intervention

Procedure:
• Immediately CR
Immediately opening non-IRA after emergency opening IRA in STEMI patients with MVD
• Staged (within 45 days) CR
Staged opening non-IRA after emergency opening IRA in STEMI patients with MVD

Locations

Country	Name	City	State
China	Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	Beijing Chao Yang Hospital, Beijing Luhe Hospital

Country where clinical trial is conducted

China, 

References & Publications (13)

Engstrøm T, Kelbæk H, Helqvist S, Høfsten DE, Kløvgaard L, Holmvang L, Jørgensen E, Pedersen F, Saunamäki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aarøe J, Jensen SE, Raungaard B, Køber L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. — View Citation

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Hannan EL, Samadashvili Z, Walford G, Holmes DR Jr, Jacobs AK, Stamato NJ, Venditti FJ, Sharma S, King SB 3rd. Culprit vessel percutaneous coronary intervention versus multivessel and staged percutaneous coronary intervention for ST-segment elevation myocardial infarction patients with multivessel disease. JACC Cardiovasc Interv. 2010 Jan;3(1):22-31. doi: 10.1016/j.jcin.2009.10.017. — View Citation

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* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Event	Including All-cause death, Ischemia driven revascularization, Nonfatal myocardial infarction and Heart failure	1 year
Secondary	All-cause death	All reasons of death	1 year
Secondary	Ischemia driven revascularization	Myocardial ischemia needs to revascularize	1 year
Secondary	Nonfatal myocardial infarction	A kind of Myocardial infarction which does not lead to death	1 year
Secondary	Heart failure	Deterioration of heart function or acute heart failure	1 year
Secondary	Cardiovascular related death	Died of cardiovascular diseases	1 year
Secondary	Stent thrombosis	Thrombosis in stent	1 year
Secondary	Dialysis or acute renal insufficiency	Dialysis or acute renal insufficiency occurred after operation	1 year
Secondary	Bleeding events	Bleeding occurred after oral administration of dual antiplatelet drugs	1 year