Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01332591
Study type	Interventional
Source	St. Anne's University Hospital Brno, Czech Republic
Contact
Status	Completed
Phase	N/A
Start date	September 2008
Completion date	December 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05133843` - Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis	N/A
Completed	`NCT01205776` - EXCEL Clinical Trial	N/A
Completed	`NCT00739466` - Biorest Liposomal Alendronate With Stenting sTudy (BLAST)	Phase 2
Completed	`NCT01182428` - XIENCE V: SPIRIT WOMEN Sub-study	Phase 4
Completed	`NCT01310309` - EXecutive Registry: Evaluating XIENCE V® in a Multi Vessel Disease	Phase 4
Completed	`NCT00531011` - EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease	Phase 4
Not yet recruiting	`NCT06052670` - Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Coronary Artery Lesions
Completed	`NCT05509296` - Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease	N/A
Not yet recruiting	`NCT05393882` - Impact of Cholesterol Level on Long-term Coronary Bypass Graft Patency
Recruiting	`NCT06397820` - Relation Between AI-QCA and Cardiac PET
Active, not recruiting	`NCT01960504` - First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)	N/A
Completed	`NCT01721096` - XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
Active, not recruiting	`NCT01342822` - Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization	Phase 4
Completed	`NCT01205789` - EXCEL Clinical Trial (Universal Registry)	N/A
Recruiting	`NCT05532605` - Effects of Mindfulness Based Therapy on Illness and Depression in Cardiac Rehab Phase-i	N/A
Completed	`NCT02066623` - Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold
Not yet recruiting	`NCT02946320` - Optimal Predilatation Technique for BVS Implantation	Phase 3
Terminated	`NCT01136915` - Kidney Damage In Patients With Severe Fall In eGFR	Phase 4
Completed	`NCT01249027` - XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
Completed	`NCT01136876` - Kidney Damage in Patients With Moderate Fall in eGFR	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy. — Prague-13

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms