Multivessel Disease Diagnosed at the Time of PPCI for STE... | NCT01332591

Studies
Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy.

NCT01332591

Sponsor

St. Anne's University Hospital Brno, Czech Republic

Status

Completed

Last Update Posted

Jan 1, 2015Estimated

Enrollment

213Actual

Phase

Not Applicable

Conditions

Coronary Artery Stenosis

Interventions

Percutaneous coronary intervention

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Mar 30, 2011

First Submission Date that Met QC Criteria

Apr 1, 2011

First Posted Date

Apr 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2014

Last Update Posted Date

Jan 1, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ota Hlinomaz, MD, PhD, Ota Hlinomaz, MD, PhD, St. Anne's University Hospital Brno, Czech RepublicPrincipal Investigator

Lead Sponsor

St. Anne's University Hospital Brno, Czech RepublicOTHER

Collaborators

Name	Class
Bulgarian Cardiac Institute	NETWORK
Tomas Bata Hospital, Czech Republic	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to find the optimal management of patients with acute myocardial infarction with ST elevations treated by primary PCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.

Detailed Description

Introduction:

Primary percutaneous coronary intervention (PPCI) of the occlussion or significant stenosis of infarct artery is a method of choice in treatment of acute myocardial infarction with ST segment elevation (STEMI). It is not clear, what is the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by primary percutaneous coronary intervention (PPCI) who have at least one significant stenosis of non-culprit coronary artery. Numerous cardiology centers perform staged PCI on significant stenoses involving the "non-infarct" coronary artery (arteries) 3-40 days after PPCI, but the benefit of this staged PCI for such patients has not yet been clearly demonstrated.

Aim of study:

The aim is to find the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by PPCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.

Hypothesis:

Our hypothesis is that complete staged revascularization of significant stenoses of the coronary arteries will improve the long-term prognosis in patients after PPCI as compared to conservative management.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

213Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Complete revascularization	Active Comparator	Percutaneous coronary intervention of "non-infarct" coronary arteries	Procedure: Percutaneous coronary intervention
Conservative management	No Intervention	standard guideline-based medical therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous coronary intervention	Procedure	PCI of significant stenoses of "non-infarct" coronary arteries	Complete revascularization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
composite endpoint of death, nonfatal acute myocardial infarction and stroke		2 years

Secondary Outcomes

Measure	Description	Time Frame
cardiovascular death		2 years
recurrent myocardial infarction		2 years
target vessel failure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with acute myocardial infarction with ST segment elevation (STEMI)
Angiographically successful primary PCI of infarct-related stenosis (TIMI flow grades II-III)
One or more other stenoses (≥70%) of "non-infarct" coronary artery (arteries) found by coronary angiography, (diameter of artery ≥ 2,5mm)
Enrollment ≥48 hours following onset of symptoms

Exclusion Criteria:

Stenosis of the left main of left coronary artery ≥ 50%
Hemodynamically significant valvular disease
Patients in cardiogenic shock during STEMI
Hemodynamic instability
Angina pectoris > grade 2 CCS lasting 1 month prior to STEMI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ota Hlinomaz, MD, PhD	+420604273627	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardioangiology, St. Anne University Hospital		Brno		65691	Czechia

Condition Browse Module

MeSH Terms

ID	Term
D023921	Coronary Stenosis
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062645	Percutaneous Coronary Intervention

Ancestor Terms

ID	Term
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided