Trial Outcomes & Findings for Contrast Nephropathy and Nitrates (NCT NCT01999517)

NCT ID: NCT01999517

Last Updated: 2019-10-29

Results Overview

The primary endpoint for this trial will be to determine the change in glomerular filtration rate after exposure to contrast media. We will compare the change in GFR before and after PCI of the group that received intravenous nitroglycerin with the change in GFR before and after PCI of the group that did not receive intravenous nitroglycerin.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

122 participants

Primary outcome timeframe

Baseline and 48 to 72 hours post-PCI

Results posted on

2019-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Intravenous Nitroglycerin Intravenous Nitroglycerin with IV Fluids	Placebo IV Fluids
Overall Study STARTED	68	54
Overall Study COMPLETED	68	54
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contrast Nephropathy and Nitrates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Nitroglycerin n=68 Participants Intravenous Nitroglycerin with IV Fluids	Placebo n=54 Participants IV Fluids	Total n=122 Participants Total of all reporting groups
Age, Continuous	77 years n=99 Participants	76 years n=107 Participants	76 years n=206 Participants
Sex: Female, Male Female	16 Participants n=99 Participants	16 Participants n=107 Participants	32 Participants n=206 Participants
Sex: Female, Male Male	52 Participants n=99 Participants	38 Participants n=107 Participants	90 Participants n=206 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	26 Participants n=99 Participants	21 Participants n=107 Participants	47 Participants n=206 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	5 Participants n=99 Participants	3 Participants n=107 Participants	8 Participants n=206 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	34 Participants n=99 Participants	27 Participants n=107 Participants	61 Participants n=206 Participants
Race/Ethnicity, Customized Race/Ethnicity · Unknown/not reported	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Region of Enrollment United States	68 Participants n=99 Participants	54 Participants n=107 Participants	122 Participants n=206 Participants
eGFR (Baseline)	58.3 mL/min n=99 Participants	59.1 mL/min n=107 Participants	58.6 mL/min n=206 Participants

PRIMARY outcome

Timeframe: Baseline and 48 to 72 hours post-PCI

Outcome measures

Outcome measures
Measure	Intravenous Nitroglycerin n=68 Participants IV Nitroglycerin with IV Fluids Intravenous Nitroglycerin IV Fluids	Placebo n=54 Participants IV Fluids IV Fluids
Change in GFR	1.8 mL/min Interval -5.9 to 6.9	-4.1 mL/min Interval -9.3 to 3.0

Adverse Events

Intravenous Nitroglycerin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intravenous Nitroglycerin n=68 participants at risk Intravenous Nitroglycerin with IV Fluids	Placebo n=54 participants at risk IV Fluids
Cardiac disorders Hypotension	5.9% 4/68 • Number of events 4 • 4 years The collection of adverse events does not differ from the clinicaltrials.gov definitions.	3.7% 2/54 • Number of events 2 • 4 years The collection of adverse events does not differ from the clinicaltrials.gov definitions.

Additional Information

Gervasio Lamas, MD

Mount Sinai Medical Center

Phone: 305-674-2162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place