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

NCT05231226 | Unknown DMC

• 1 other identifier: 2021-20
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ST-elevation Myocardial Infarction; Multivessel Coronary Disease

Keywords

Acute ST segment elevation myocardial infarction; Multi vessel lesions; Complete revascularization; Non infarct related arteries; Major cardiovascular adverse events

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Event

  Including All-cause death, Ischemia driven revascularization, Nonfatal myocardial infarction and Heart failure

  1 year

Secondary Outcomes (8)

• All-cause death

  1 year

• Ischemia driven revascularization

  1 year

• Nonfatal myocardial infarction

  1 year

• Heart failure

  1 year

• Cardiovascular related death

  1 year

Study Arms (2)

Immediately CR group

EXPERIMENTAL

Immediately open non-IRA after successful emergency PCI of IRA in STEMI patients with MVD

Procedure: Immediately CR

Staged (within 45 days) CR group

ACTIVE COMPARATOR

Strategy of opening non-IRA by stages after emergency PCI of IRA in STEMI patients with MVD

Procedure: Staged (within 45 days) CR

Interventions

Immediately CR PROCEDURE

Immediately opening non-IRA after emergency opening IRA in STEMI patients with MVD

Immediately CR group

Staged (within 45 days) CR PROCEDURE

Staged opening non-IRA after emergency opening IRA in STEMI patients with MVD

Staged (within 45 days) CR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Onset of the spontaneous acute STEMI (24 hours).
• The anatomical structure of coronary artery is suitable for complete revascularization by PCI.
• It is suitable for PCI through radial artery or femoral artery.
• Be able to fully identify Infarct-related artery（IRA）.
• 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.
• After IRA revascularization the thrombolysis in myocardial infarction (TIMI) blood flow is in grade 3.
• 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.
• Patient who has signed informed consent

You may not qualify if:

• 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.
• The duration of cardiopulmonary resuscitation is more than 10 minutes.
• Emergency coronary artery bypass grafting (CABG) is needed.
• Previous coronary-artery bypass grafting surgery.
• Hybrid revascularization is planned.
• Coronary dissection.
• Stent thrombosis.
• 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.
• Acute myocardial infarction complicated with severe mechanical complications, defined as acute severe mitral regurgitation, ventricular septal perforation and cardiac free wall rupture / pericardial tamponade.
• Severe renal failure (EGFR \< 30ml / min) or dialysis treatment is required.
• Chronic total occlusion of main coronary artery.
• Complex bifurcation lesions requiring dual stent treatment.
• Stenosis of Left main coronary artery≥ 50% or stenosis of left anterior descending coronary artery and circumflex coronary artery ≥ 70%.
• Coronary, cerebrovascular or peripheral revascularization is planned.
• Cardiac surgery or other surgical treatment is planned.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Beijing Chao Yang Hospital: collaborator
• Beijing Luhe Hospital: collaborator

Study Sites (1)

Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (13)

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  PMID: 25399277 BACKGROUND

• Sorajja P, Gersh BJ, Cox DA, McLaughlin MG, Zimetbaum P, Costantini C, Stuckey T, Tcheng JE, Mehran R, Lansky AJ, Grines CL, Stone GW. Impact of multivessel disease on reperfusion success and clinical outcomes in patients undergoing primary percutaneous coronary intervention for acute myocardial infarction. Eur Heart J. 2007 Jul;28(14):1709-16. doi: 10.1093/eurheartj/ehm184. Epub 2007 Jun 7.

  PMID: 17556348 BACKGROUND

• Politi L, Sgura F, Rossi R, Monopoli D, Guerri E, Leuzzi C, Bursi F, Sangiorgi GM, Modena MG. A randomised trial of target-vessel versus multi-vessel revascularisation in ST-elevation myocardial infarction: major adverse cardiac events during long-term follow-up. Heart. 2010 May;96(9):662-7. doi: 10.1136/hrt.2009.177162. Epub 2009 Sep 23.

  PMID: 19778920 BACKGROUND

• 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.

  PMID: 20129564 BACKGROUND

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• Montone RA, Niccoli G, Crea F, Jang IK. Management of non-culprit coronary plaques in patients with acute coronary syndrome. Eur Heart J. 2020 Oct 1;41(37):3579-3586. doi: 10.1093/eurheartj/ehaa481.

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  PMID: 23991625 BACKGROUND

• Gershlick AH, Khan JN, Kelly DJ, Greenwood JP, Sasikaran T, Curzen N, Blackman DJ, Dalby M, Fairbrother KL, Banya W, Wang D, Flather M, Hetherington SL, Kelion AD, Talwar S, Gunning M, Hall R, Swanton H, McCann GP. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015 Mar 17;65(10):963-72. doi: 10.1016/j.jacc.2014.12.038.

  PMID: 25766941 BACKGROUND

• Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober 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. doi: 10.1016/s0140-6736(15)60648-1.

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• Smits PC, Abdel-Wahab M, Neumann FJ, Boxma-de Klerk BM, Lunde K, Schotborgh CE, Piroth Z, Horak D, Wlodarczak A, Ong PJ, Hambrecht R, Angeras O, Richardt G, Omerovic E; Compare-Acute Investigators. Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction. N Engl J Med. 2017 Mar 30;376(13):1234-1244. doi: 10.1056/NEJMoa1701067. Epub 2017 Mar 18.

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• Kornowski R, Mehran R, Dangas G, Nikolsky E, Assali A, Claessen BE, Gersh BJ, Wong SC, Witzenbichler B, Guagliumi G, Dudek D, Fahy M, Lansky AJ, Stone GW; HORIZONS-AMI Trial Investigators. Prognostic impact of staged versus "one-time" multivessel percutaneous intervention in acute myocardial infarction: analysis from the HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trial. J Am Coll Cardiol. 2011 Aug 9;58(7):704-11. doi: 10.1016/j.jacc.2011.02.071.

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MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Hou

  Beijing Anzhen Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaotong Hou, MD,PhD

CONTACT

8610 64456631; xt.hou@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: February 9, 2022
• Study Start: March 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)