Trial Outcomes & Findings for Electrophysiological Effects of Late PCI After MI (NCT NCT00119847)

NCT ID: NCT00119847

Last Updated: 2022-05-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: Baseline, one year
• Results posted on: 2022-05-18

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	149	151
Overall Study COMPLETED	118	119
Overall Study NOT COMPLETED	31	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electrophysiological Effects of Late PCI After MI

Baseline characteristics by cohort

Measure	PCI+Optimal Medical Therapy n=149 Participants 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 n=151 Participants Optimal medical therapy alone Optimal Medical Therapy: Guideline-directed drug therapies after MI	Total n=300 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 10.5 • n=5 Participants	57.6 years STANDARD_DEVIATION 10.5 • n=7 Participants	57.4 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	24 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants	127 Participants n=7 Participants	238 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	115 Participants n=5 Participants	117 Participants n=7 Participants	232 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, one year

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

Outcome measures

Measure	PCI+Optimal Medical Therapy n=118 Participants 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 n=119 Participants Optimal medical therapy alone Optimal Medical Therapy: Guideline-directed drug therapies after MI
Short-termed Fractal Scaling Exponent (Alpha 1)	0.01 unit-less Standard Deviation 0.34	-0.03 unit-less Standard Deviation 0.32

SECONDARY outcome

Timeframe: Baseline and one year

Variability in T wave morphology, change between baseline and one year

Outcome measures

Measure	PCI+Optimal Medical Therapy n=104 Participants 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 n=103 Participants Optimal medical therapy alone Optimal Medical Therapy: Guideline-directed drug therapies after MI
T-wave Variability	-6.3 Microvolts Standard Deviation 25.1	-3.4 Microvolts Standard Deviation 31.0

SECONDARY outcome

Timeframe: Baseline and one year

Signal-averaged ECG

Outcome measures

Measure	PCI+Optimal Medical Therapy n=90 Participants 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 n=81 Participants Optimal medical therapy alone Optimal Medical Therapy: Guideline-directed drug therapies after MI
Filtered QRS Duration	1.5 Milliseconds Standard Deviation 12.4	3.7 Milliseconds Standard Deviation 11.8

Adverse Events

PCI+Optimal Medical Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Optimal Medical Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eric J. Rashba

Stony Brook University

Phone: 631-444-3575

Email: eric.rashba@stonybrookmedicine.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place