Contrast-induced Acute Kidney Injury
Conditions
Keywords
remote ischemic conditioning, contrast-induced nephropathy, cardiac catheterization, coronary artery disease
Brief summary
This a prospective, double-blind, sham-controlled, randomized clinical trial to study the effects of remote ischemic preconditioning on acute kidney injury, vascular and renal biomarkers in patients with non-ST elevation myocardial infarction and unstable angina undergoing coronary angiography and/or percutaneous coronary intervention.
Detailed description
The BRICK study is a prospective, double-blind, sham-controlled, randomized clinical trial in patients with non-ST elevation myocardial infarction and unstable angina undergoing coronary angiography and/or percutaneous coronary intervention who are at high risk for acute kidney injury. The study will investigate the effects of remote ischemic preconditioning before cardiac catheterization on rate of acute kidney injury and novel biomarkers of renal injury/protection within 48hrs of coronary angiography and/or percutaneous coronary intervention.
Interventions
DEVICERIPC
Remote ischemic preconditioning
DEVICESham-RIPC
Control
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Oladipupo Olafiranye, MD, MS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with non-ST elevation myocardial infarction or unstable angina * Referral for cardiac catheterization and percutaneous coronary intervention * Contrast-induced acute kidney injury risk score of ≥11
Exclusion criteria
* Inability to give informed consent * unstable blood pressure (systolic blood pressure \> 200 or \<90 mmHg) * History of allergy to contrast media * Peripheral vascular disease of upper limb * Renal disease requiring dialysis * Placement of arteriovenous fistula and arteriovenous graft
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Acute Kidney Injury | 24-48 hours post coronary angiography | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7) | 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. |
| Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event | 6 months post coronary angiography | Composite outcome including rehospitalization for myocardial infarction, hospitalization for heart failure, repeat revascularization, stroke, and cardiac death. |
| Number of Patients With Major Adverse Kidney Event | 6 months post coronary angiography. | Composite outcome including persistent renal impairment, use of renal replacement therapy, and all-cause death. |
| Cyclic Guanylate Monophosphate (cGMP) Level | 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 54 |
| 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 | 55 |
| Total | 109 |
Baseline characteristics
| Characteristic | RIPC Group | Total | Sham-RIPC Group |
|---|---|---|---|
| Age, Continuous | 76 years | 75 years | 75 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 109 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 50 Participants | 101 Participants | 51 Participants |
| Region of Enrollment United States | 54 participants | 109 participants | 55 participants |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Male | 45 Participants | 92 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 54 | 4 / 55 |
| other Total, other adverse events | 5 / 54 | 14 / 55 |
| serious Total, serious adverse events | 4 / 54 | 8 / 55 |
Outcome results
Primary
Number of Patients With Acute Kidney Injury
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RIPC Group | Number of Patients With Acute Kidney Injury | 8 Participants |
| Sham-RIPC Group | Number of Patients With Acute Kidney Injury | 16 Participants |
Secondary
Cyclic Guanylate Monophosphate (cGMP) Level
Higher level of cyclic guanylate monophosphate is associated with greater vessel dilatation and blood flow. Cyclic GMP was measured in nanomolar (nM).
Time frame: 0-48 Hrs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RIPC Group | Cyclic Guanylate Monophosphate (cGMP) Level | Baseline | 60.12 nM | Standard Deviation 84.71 |
| RIPC Group | Cyclic Guanylate Monophosphate (cGMP) Level | Post RIPC | 68.28 nM | Standard Deviation 112.56 |
| RIPC Group | Cyclic Guanylate Monophosphate (cGMP) Level | 24 Hours post coronary angiogram | 62.91 nM | Standard Deviation 89.36 |
| RIPC Group | Cyclic Guanylate Monophosphate (cGMP) Level | 48 Hours post coronary angiogram | 65.61 nM | Standard Deviation 96.01 |
| Sham-RIPC Group | Cyclic Guanylate Monophosphate (cGMP) Level | 48 Hours post coronary angiogram | 45.04 nM | Standard Deviation 65 |
| Sham-RIPC Group | Cyclic Guanylate Monophosphate (cGMP) Level | Baseline | 55.19 nM | Standard Deviation 147.46 |
| Sham-RIPC Group | Cyclic Guanylate Monophosphate (cGMP) Level | 24 Hours post coronary angiogram | 55.22 nM | Standard Deviation 116.02 |
| Sham-RIPC Group | Cyclic Guanylate Monophosphate (cGMP) Level | Post RIPC | 59.66 nM | Standard Deviation 181.04 |
Secondary
Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event
Composite outcome including rehospitalization for myocardial infarction, hospitalization for heart failure, repeat revascularization, stroke, and cardiac death.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RIPC Group | Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event | 9 Participants |
| Sham-RIPC Group | Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event | 20 Participants |
Secondary
Number of Patients With Major Adverse Kidney Event
Composite outcome including persistent renal impairment, use of renal replacement therapy, and all-cause death.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RIPC Group | Number of Patients With Major Adverse Kidney Event | 4 Participants |
| Sham-RIPC Group | Number of Patients With Major Adverse Kidney Event | 6 Participants |
Secondary
The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7)
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.
Time frame: 0-48hrs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RIPC Group | 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 |
| RIPC Group | 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 |
| RIPC Group | 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 |
| RIPC Group | 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 |
| Sham-RIPC Group | The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7) | 48hrs post coronary angiography | 0.89 (ng/ml)2/1000 | Standard Deviation 0.84 |
| Sham-RIPC Group | The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7) | Baseline | 0.51 (ng/ml)2/1000 | Standard Deviation 0.51 |
| Sham-RIPC Group | 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 0.89 |
| Sham-RIPC Group | The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7) | Post RIPC/Sham-RIPC | .49 (ng/ml)2/1000 | Standard Deviation 0.56 |