Trial Outcomes & Findings for Biochemical Effects of Remote Ischemic Pre-Conditioning on Contrast-induced Acute Kidney Injury (NCT NCT03236441)

Last Updated: 2025-01-09

Results Overview

acute kidney injury is defined as a relative increase in serum creatinine of ≥ 0.3mg/dl within 48 hours post catheterization compared with baseline creatinine before coronary angiography.

Recruitment status

COMPLETED

Study phase

Target enrollment

110 participants

Primary outcome timeframe

24-48 hours post coronary angiography

Results posted on

2025-01-09

Participant Flow

Out of 110 patients enrolled in this study, 1 patient withdrew after signing informed consent and prior to randomization. As a result, a total of 109 patients were randomized or assigned to RIPC or Sham-RIPC groups.

Participant milestones

Participant milestones
Measure	RIPC Group 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes RIPC: Remote ischemic preconditioning	Sham-RIPC Group 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control) Sham-RIPC: Control
Overall Study STARTED	54	55
Overall Study COMPLETED	54	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Biochemical Effects of Remote Ischemic Pre-Conditioning on Contrast-induced Acute Kidney Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RIPC Group n=54 Participants 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes RIPC: Remote ischemic preconditioning	Sham-RIPC Group n=55 Participants 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control) Sham-RIPC: Control	Total n=109 Participants Total of all reporting groups
Age, Continuous	76 years n=5 Participants	75 years n=7 Participants	75 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	47 Participants n=7 Participants	92 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	51 Participants n=7 Participants	101 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants	55 participants n=7 Participants	109 participants n=5 Participants

PRIMARY outcome

Timeframe: 24-48 hours post coronary angiography

Population: 54 patients in the RIPC group and 55 patients in the sham-RIPC group were included in the primary outcome analysis.

acute kidney injury is defined as a relative increase in serum creatinine of ≥ 0.3mg/dl within 48 hours post catheterization compared with baseline creatinine before coronary angiography.

Outcome measures

Outcome measures
Measure	RIPC Group n=54 Participants 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes RIPC: Remote ischemic preconditioning	Sham-RIPC Group n=55 Participants 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control) Sham-RIPC: Control
Number of Patients With Acute Kidney Injury	8 Participants	16 Participants

SECONDARY outcome

Timeframe: 0-48hrs

Novel renal biomarker. The product of urinary tissue inhibitor of metalloproteinases 2 and insulin-like growth factor-binding protein 7 is measured and reported as a single test in (ng/ml)2/1000 unit. Higher value in general indicates higher risk of acute kidney injury. The range is between 0.3 and 10.

Outcome measures

Outcome measures
Measure	RIPC Group n=54 Participants 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes RIPC: Remote ischemic preconditioning	Sham-RIPC Group n=55 Participants 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control) Sham-RIPC: Control
The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7) Baseline	0.39 (ng/ml)2/1000 Standard Deviation 0.51	0.51 (ng/ml)2/1000 Standard Deviation 0.51
The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7) Post RIPC/Sham-RIPC	0.71 (ng/ml)2/1000 Standard Deviation 1.58	.49 (ng/ml)2/1000 Standard Deviation .56
The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7) 24hrs post coronary angiography	0.67 (ng/ml)2/1000 Standard Deviation 0.66	0.67 (ng/ml)2/1000 Standard Deviation 0.89
The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7) 48hrs post coronary angiography	0.68 (ng/ml)2/1000 Standard Deviation 0.66	0.89 (ng/ml)2/1000 Standard Deviation 0.84

SECONDARY outcome

Timeframe: 6 months post coronary angiography

Population: Patients with unstable angina and non-ST segment elevation myocardial infarction at high risk for acute kidney injury referred for coronary angiography and or percutaneous coronary angiography.

Composite outcome including rehospitalization for myocardial infarction, hospitalization for heart failure, repeat revascularization, stroke, and cardiac death.

Outcome measures

Outcome measures
Measure	RIPC Group n=54 Participants 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes RIPC: Remote ischemic preconditioning	Sham-RIPC Group n=55 Participants 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control) Sham-RIPC: Control
Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event	9 Participants	20 Participants

SECONDARY outcome

Timeframe: 6 months post coronary angiography.

Composite outcome including persistent renal impairment, use of renal replacement therapy, and all-cause death.

Outcome measures

Outcome measures
Measure	RIPC Group n=54 Participants 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes RIPC: Remote ischemic preconditioning	Sham-RIPC Group n=55 Participants 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control) Sham-RIPC: Control
Number of Patients With Major Adverse Kidney Event	4 Participants	6 Participants

SECONDARY outcome

Timeframe: 0-48 Hrs

Higher level of cyclic guanylate monophosphate is associated with greater vessel dilatation and blood flow. Cyclic GMP was measured in nanomolar (nM).

Outcome measures

Outcome measures
Measure	RIPC Group n=54 Participants 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes RIPC: Remote ischemic preconditioning	Sham-RIPC Group n=55 Participants 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control) Sham-RIPC: Control
Cyclic Guanylate Monophosphate (cGMP) Level Baseline	60.12 nM Standard Deviation 84.71	55.19 nM Standard Deviation 147.46
Cyclic Guanylate Monophosphate (cGMP) Level Post RIPC	68.28 nM Standard Deviation 112.56	59.66 nM Standard Deviation 181.04
Cyclic Guanylate Monophosphate (cGMP) Level 24 Hours post coronary angiogram	62.91 nM Standard Deviation 89.36	55.22 nM Standard Deviation 116.02
Cyclic Guanylate Monophosphate (cGMP) Level 48 Hours post coronary angiogram	65.61 nM Standard Deviation 96.01	45.04 nM Standard Deviation 65.00

Adverse Events

RIPC Group

Serious events: 4 serious events

Other events: 5 other events

Deaths: 4 deaths

Sham-RIPC Group

Serious events: 8 serious events

Other events: 14 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	RIPC Group n=54 participants at risk 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes RIPC: Remote ischemic preconditioning	Sham-RIPC Group n=55 participants at risk 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control) Sham-RIPC: Control
Cardiac disorders Repeat Coronary Revascularization	7.4% 4/54 • Up to 6 months	10.9% 6/55 • Up to 6 months
Nervous system disorders Stroke	0.00% 0/54 • Up to 6 months	3.6% 2/55 • Up to 6 months

Other adverse events

Other adverse events
Measure	RIPC Group n=54 participants at risk 3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes RIPC: Remote ischemic preconditioning	Sham-RIPC Group n=55 participants at risk 3 cycles of blood pressure cuff inflations to non-occlusive pressure of 10 mmHg for 5 minutes and deflation for 5 minutes (Control) Sham-RIPC: Control
Cardiac disorders Major adverse cardiovascular and cerebrovascular events	9.3% 5/54 • Up to 6 months	25.5% 14/55 • Up to 6 months
Renal and urinary disorders Major Adverse Kidney Events	7.4% 4/54 • Up to 6 months	10.9% 6/55 • Up to 6 months

Additional Information

Oladipupo Olafiranye, MD, MS

UT Southwestern Medical Center

Phone: 2148572923

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place