Coronary Artery Stenosis Clinical Trial
Official title:
Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin as New Biomarker in Patients With Moderate Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320
NCT number | NCT01136876 |
Other study ID # | IOP-117 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | November 2010 |
Est. completion date | November 2012 |
Verified date | September 2013 |
Source | Bracco Diagnostics, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR
Status | Completed |
Enrollment | 57 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - At least 18 years of age and provides informed consent - Scheduled to undergo percutaneous coronary intervention - Documented pre-dose Estimated glomerular filtration rate (eGFR) of greater than or equal to 30 mL/min/1.73 m squared and less than or equal to 59 mL/min/1.73 m squared Exclusion Criteria: - Pregnant or lactating females - Severe congestive heart failure - History of hyperthyroidism; - Unstable renal function - Emergency PCI - History of hypersensitivity to iodinated contrast agents - Receiving diuretics to prevent acute renal injury |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Heart Institute | Montréal | Quebec |
United States | UMDNJ - RWJ Medical School | New Brunswick | New Jersey |
United States | Research Cooperative, St. John's Hospital | Springfield | Illinois |
United States | The Institute for Clinical Research at Holy Name Medical Center | Teaneck | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Bracco Diagnostics, Inc |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration | Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media. | Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05133843 -
Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
|
N/A | |
Completed |
NCT01205776 -
EXCEL Clinical Trial
|
N/A | |
Completed |
NCT01332591 -
Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy.
|
N/A | |
Completed |
NCT00739466 -
Biorest Liposomal Alendronate With Stenting sTudy (BLAST)
|
Phase 2 | |
Completed |
NCT01182428 -
XIENCE V: SPIRIT WOMEN Sub-study
|
Phase 4 | |
Completed |
NCT00531011 -
EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease
|
Phase 4 | |
Completed |
NCT01310309 -
EXecutive Registry: Evaluating XIENCE V® in a Multi Vessel Disease
|
Phase 4 | |
Not yet recruiting |
NCT06052670 -
Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Coronary Artery Lesions
|
||
Completed |
NCT05509296 -
Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease
|
N/A | |
Not yet recruiting |
NCT05393882 -
Impact of Cholesterol Level on Long-term Coronary Bypass Graft Patency
|
||
Recruiting |
NCT06397820 -
Relation Between AI-QCA and Cardiac PET
|
||
Active, not recruiting |
NCT01960504 -
First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)
|
N/A | |
Completed |
NCT01721096 -
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
|
||
Active, not recruiting |
NCT01342822 -
Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization
|
Phase 4 | |
Completed |
NCT01205789 -
EXCEL Clinical Trial (Universal Registry)
|
N/A | |
Recruiting |
NCT05532605 -
Effects of Mindfulness Based Therapy on Illness and Depression in Cardiac Rehab Phase-i
|
N/A | |
Completed |
NCT02066623 -
Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold
|
||
Not yet recruiting |
NCT02946320 -
Optimal Predilatation Technique for BVS Implantation
|
Phase 3 | |
Terminated |
NCT01136915 -
Kidney Damage In Patients With Severe Fall In eGFR
|
Phase 4 | |
Completed |
NCT01249027 -
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
|