Trial Outcomes & Findings for Nitric Oxide in Myocardial Infarction Size (NCT NCT00568061)

Results Overview

The primary endpoint - mean percent of the myocardial infarction size to the fraction of left ventricular size at 48-72 hours was measured by contrast-enhanced cardiac Magnetic Resonance Imaging (MRI).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

48-72 hours

Results posted on

2019-11-21

Participant Flow

7 medical centers enrolled subjects. A total of 29 subjects were enrolled in the study.

Participant milestones

Participant milestones
Measure	Inhaled Nitric Oxide Inhaled Nitric Oxide administered at 80 ppm	Nitrogen Gas Nitrogen Gas (Placebo) administered at 80 ppm
Overall Study STARTED	13	16
Overall Study COMPLETED	8	14
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Inhaled Nitric Oxide Inhaled Nitric Oxide administered at 80 ppm	Nitrogen Gas Nitrogen Gas (Placebo) administered at 80 ppm
Overall Study Inclusion / exclusion criteria	5	1
Overall Study Adverse Event	0	1

Baseline Characteristics

Nitric Oxide in Myocardial Infarction Size

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inhaled Nitric Oxide n=13 Participants Inhaled Nitric Oxide administered at 80ppm	Nitrogen Gas n=16 Participants Nitrogen Gas (Placebo) administered at 80ppm	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	62.3 years STANDARD_DEVIATION 11.71 • n=5 Participants	63.8 years STANDARD_DEVIATION 12.41 • n=7 Participants	63.1 years STANDARD_DEVIATION 11.91 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	16 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 48-72 hours

Population: Analysis was per intent to treat population

The primary endpoint - mean percent of the myocardial infarction size to the fraction of left ventricular size at 48-72 hours was measured by contrast-enhanced cardiac Magnetic Resonance Imaging (MRI).

Outcome measures

Outcome measures
Measure	Inhaled Nitric Oxide n=13 Participants Inhaled Nitric Oxide administered at 80ppm	Nitrogen Gas n=16 Participants Nitrogen Gas (Placebo) administered at 80ppm
Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size	15.8 percent of myocardial infarction size Standard Deviation 8.99	12.5 percent of myocardial infarction size Standard Deviation 11.68

SECONDARY outcome

Timeframe: 48-72 hours

Population: All efforts have been exhausted to locate data for this historical trial - the validated summary tables and Clinical Study Report (CSR) are no longer accessible.