Electrophysiological Effects of Late PCI After MI

NCT00119847 | Completed Results DMC

• 2 other identifiers: 221R01HL072906
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if opening blocked arteries with heart balloons and stents prevents heart rhythm problems in individuals 3 to 28 days after a heart attack.

Conditions

Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Arrhythmia; Ventricular Fibrillation

Keywords

Stents, myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Short-termed Fractal Scaling Exponent (Alpha 1)

  Nonlinear measurement of heart rate variability, change between baseline and 1 year is the primary outcome.

  Baseline, one year

Secondary Outcomes (2)

• T-wave Variability

  Baseline and one year

• Filtered QRS Duration

  Baseline and one year

Study Arms (2)

PCI+MED

EXPERIMENTAL

Percutaneous Coronary Intervention (PCI) with angioplasty and stenting of the infarct-related artery and optimal medical therapy

Procedure: PCI; Drug: Optimal Medical Therapy

MED

EXPERIMENTAL

Optimal medical therapy alone

Drug: Optimal Medical Therapy

Interventions

PCI PROCEDURE

Also known as: Angioplasty and stenting of the infarct-related artery

PCI+MED

Optimal Medical Therapy DRUG

Guideline-directed drug therapies after MI

MED; PCI+MED

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Has experienced a heart attack 3 to 28 days prior to study entry
• Persistently occluded IRA defined as either: 1) Thrombolysis in Myocardial Infarction (TIMI) 0, with no flow beyond the site of occlusion; or 2) TIMI 1, with penetration of dye beyond the site of occlusion without dye reaching the distal vessel
• LVEF less than 50% or proximal occlusion in a large vessel
• Normal sinus rhythm
• QRS duration less than 120 ms
• Able to return for follow-up assessment of arrhythmia markers one month and one year after study entry

You may not qualify if:

• Has a clinical indication for revascularization (post-heart attack angina at rest; significant inducible ischemia; or significant left main or triple vessel disease requiring PTCA or CABG)
• Current serious illness or condition that limits 3-year survival
• Severe valvular disease
• Chronic total occlusion
• New York Heart Association Class III-IV congestive heart failure
• Prior left ventricular aneurysm in the recent heart attack location
• Is a poor candidate for PTCA/stent on the basis of angiographic or clinical criteria
• Cannot medically survive anticoagulation during PTCA/stent or antiplatelet therapy after stent
• Pregnant

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Related Publications (3)

• Rashba EJ. Assessment of ventricular repolarization abnormalities in congenital long QT syndrome. J Cardiovasc Electrophysiol. 2004 May;15(5):557-9. doi: 10.1046/j.1540-8167.2004.04022.x. No abstract available.

  PMID: 15149425 BACKGROUND

• Rashba EJ. Should T-wave alternans testing be used to risk stratify candidates for prophylactic implantable cardioverter-defibrillator therapy? Heart Rhythm. 2005 Mar;2(3):242-4. doi: 10.1016/j.hrthm.2004.12.015. No abstract available.

  PMID: 15851311 BACKGROUND

• Rashba EJ, Lamas GA, Couderc JP, Hollist SM, Dzavik V, Ruzyllo W, Fridrich V, Buller CE, Forman SA, Kufera JA, Carvalho AC, Hochman JS; OAT-EP Investigators. Electrophysiological effects of late percutaneous coronary intervention for infarct-related coronary artery occlusion: the Occluded Artery Trial-Electrophysiological Mechanisms (OAT-EP). Circulation. 2009 Feb 17;119(6):779-87. doi: 10.1161/CIRCULATIONAHA.108.808626. Epub 2009 Feb 2.

  PMID: 19188505 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Arrhythmias, Cardiac; Ventricular Fibrillation

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Myocardial Ischemia; 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

Results Point of Contact

• Title: Dr. Eric J. Rashba
• Organization: Stony Brook University

eric.rashba@stonybrookmedicine.edu

631-444-3575

Study Officials

• Eric J. Rashba, MD

  Stony Brook University Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: Associate Professor

Study Record Dates

• First Submitted: July 6, 2005
• First Posted: July 14, 2005
• Study Start: September 1, 2002
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: May 18, 2022
• Results First Posted: August 23, 2018

Record last verified: 2022-05

Locations

US (1)