Comparison Between Two Revascularization Strategies in MVD Patients With Uncomplicated ST-elevation MI

NCT04582175 | Completed

• 1 other identifier: Uoradea
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to compare major adverse cardiac and cerebrovascular events(MACCE) and mortality at one year between two strategies: complete revascularization including non-culprit lesions percutaneous coronary intervention(PCI) during primary PCI(PPCI) versus complete revascularisation during the same hospital admission in multi-vascular coronary artery disease(MVD) patients presenting with ST-elevation myocardial infarction(STEMI) uncomplicated by cardiogenic shock.

Conditions

STEMI

Keywords

PPCI, multivessel coronary artery disease, STEMI

Outcome Measures

Primary Outcomes (2)

• one year all-cause mortality

  death at one year

  one year

• MACCE at one year

  major adverse cardiac and cerebrovascular events including cardiac death, stroke, symptom-driven revascularization, myocardial infarction

  one year

Study Arms (2)

group A

patients who received complete revascularization by angioplasty during the PPCI

Procedure: angioplasty

Group B

patients who underwent complete revascularization by angioplasty in a staged procedure

Procedure: angioplasty

Interventions

angioplasty PROCEDURE

angioplasty of all non-culprit lesions

Group B; group A

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

multivessel patients with STEMI uncomplicated by cardiogenic shock

You may qualify if:

• Men and women with successful PCI (preferably using a drug-eluting stent) to the culprit lesion for STEMI ( PCI for STEMI should be primary PCI in the first 12 hours after symptom onset) and complete revascularization of non-culprit lesions during the index PPCI procedure or during a different procedure performed before index hospital discharge.
• Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has:
• At least 75% diameter stenosis (visual estimation) or
• At least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ≤ 0.80
• Age between 18 and 90 years
• Written informed consent could be obtained from all the patients

You may not qualify if:

• Rescue PCI for failed fibrinolysis or a combination strategy where PCI is performed routinely 3-12 hours after fibrinolysis
• Cardiogenic shock
• Non-cardiovascular known co-morbidity reducing life expectancy to \< 2 years
• Any factor precluding 1year follow-up
• Prior Coronary Artery Bypass Graft (CABG) Surgery
• A different operator from the previously designated
• Unable to provide consent for any other reason

Sponsors & Collaborators

• University of Oradea: lead

Study Sites (1)

Spitalul Clinic Judetean de Urgenta Oradea

Oradea, Bihor County, Romania

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Mihnea-Traian T Nichita-Brendea, MD

  Spitalul Clinic Judetean de Urgenta Oradea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: October 9, 2020
• Study Start: July 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 5, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)