Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction

NCT01642784 | Completed

• 1 other identifier: 2.0, 2011-11-24
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 8

Brief Summary

Objective of this registry study is to compare strategy of complete vs. target lesion-only primary PCI (percutaneous coronary intervention) in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.

Conditions

Myocardial Infarction

Keywords

STEMI; NSTEMI; revascularization; stents

Outcome Measures

Primary Outcomes (5)

• Death

  Death rates at 12-month clinical follow-up

  At 12 months

• Stent thrombosis

  Rates of stent thrombosis at 12-month follow-up according to ARC definition

  At 12 months

• reMI (repeat myocardial infarctions)

  Rates of reMI at 12 months

  At 12 months

• urgent TVR (target vessel revascularization) at 12 months

  Rates of urgent TVR at 12 months

  12 months and at 12 months

• Planned TVR

  Rates of planned TVR (PCI + CABG) at 12 months

  At 12 months

Secondary Outcomes (4)

• Angiographic complications

  During hospitalization

• Target Vessel Revascularization (PCI and/or CABG (coronary artery bypass graft))

  During hospitalization and at 12 months

• Complete contrast dose in ml

  During hospitalization and at 12 months

• Complete radiation dose in mGy

  During hospitalization and at 12 months

Study Arms (2)

Culprit lesion IRA revascularization

Culprit lesion IRA revascularization

Device: Primary PCI of culprit lesion in IRA with drug eluting stent (DES)

Complete IRA revascularization

Complete IRA revascularization

Device: Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES

Interventions

Primary PCI of culprit lesion in IRA with drug eluting stent (DES) DEVICE

Primary PCI of culprit lesion in IRA with drug eluting stent (DES)

Culprit lesion IRA revascularization

Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES DEVICE

Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES

Complete IRA revascularization

Eligibility Criteria

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

Study Population

Study population will comprise of approx. 200 patients (males and females) with the diagnosis of STEMI or NSTEMI and at least two independent critical lesions in infarct related artery (one of which is considered as target/culprit lesion that have caused the myocardial infarction and requires immediate PCI). Patients enrolled to the registry must meet all the eligibility criteria.

You may qualify if:

• Diagnosis of STEMI or NSTEMI (according to ESC 2007 definition)
• Over 18 years of age
• Presence of two critical lesions requiring PCI in IRA (LAD (left anterior descending), Cx (circumflex), RCA (right coronary artery)):
• Target/culprit lesion which requires immediate stenting (\>50 - 100%) and
• Second critical lesion (70-90%).

You may not qualify if:

• Terminal illness with life expectancy less \<1 year or active cancer disease,
• Pregnancy or possibility of pregnancy
• Second critical lesion in IRA \>90% or occlusion
• Contraindications to PCI or/and stent implantation
• Con-current participation in another clinical study that did not meet its primary end-point

Sponsors & Collaborators

• Fundacja Ośrodek Badań Medycznych: lead

Study Sites (8)

Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.

Krakow, 30-693, Poland

Location

Centrum Kardiologii Inwazyjnej GVM Carint

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Centrum Kardiologii Inwazyjnej GVM Carint

Oświecim, 32-600, Poland

Location

Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie

Pińczów, Poland

Location

Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ

Sanok, 38-500, Poland

Location

Pracownia Hemodynamiki Szpital im. E. Szczeklika

Tarnów, 33-100, Poland

Location

I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny

Warsaw, 02-097, Poland

Location

Departament of Cardiology, University Hospital, Ljubljana

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Bogdan Januś, MD, PhD

  Pracownia Hemodynamiki Szpital im. E. Szczeklika

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: July 17, 2012
• Study Start: November 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 3, 2013

Record last verified: 2013-07

Locations

SL (1); PL (7)