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Electrophysiological Effects of Late PCI After MI

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ClinicalTrials.gov Identifier: NCT00119847
Recruitment Status : Completed
First Posted : July 14, 2005
Results First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Eric Rashba, University of Maryland

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Coronary Disease
Arrhythmia
Ventricular Fibrillation
Interventions: Procedure: PCI
Drug: Optimal Medical Therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
PCI+Optimal Medical Therapy

PCI with angioplasty and stenting of the infarct-related artery and optimal medical therapy

Optimal Medical Therapy: Guideline-directed drug therapies after MI

Optimal Medical Therapy

Optimal medical therapy alone

Optimal Medical Therapy: Guideline-directed drug therapies after MI


Participant Flow:   Overall Study
    PCI+Optimal Medical Therapy   Optimal Medical Therapy
STARTED   149   151 
COMPLETED   118   119 
NOT COMPLETED   31   32 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
PCI+Optimal Medical Therapy

PCI with angioplasty and stenting of the infarct-related artery and optimal medical therapy

PCI

Optimal Medical Therapy: Guideline-directed drug therapies after MI

Optimal Medical Therapy

Optimal medical therapy alone

Optimal Medical Therapy: Guideline-directed drug therapies after MI

Total Total of all reporting groups

Baseline Measures
   PCI+Optimal Medical Therapy   Optimal Medical Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 149   151   300 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.2  (10.5)   57.6  (10.5)   57.4  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      38  25.5%      24  15.9%      62  20.7% 
Male      111  74.5%      127  84.1%      238  79.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3   2.0%      4   2.6%      7   2.3% 
White      115  77.2%      117  77.5%      232  77.3% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      31  20.8%      30  19.9%      61  20.3% 


  Outcome Measures

1.  Primary:   Short-termed Fractal Scaling Exponent (Alpha 1)   [ Time Frame: Baseline, one year ]

2.  Secondary:   T-wave Variability   [ Time Frame: Baseline and one year ]

3.  Secondary:   Filtered QRS Duration   [ Time Frame: Baseline and one year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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