Percutaneous Coronary Intervention PatientsNCT04703049
The Effect of Whole Blood Viscosity on Contrast-Induced Nephropathy Development in Patients Undergoing Percutaneous Coronary Intervention
An observational study of Percutaneous Coronary Intervention Patients, run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
Trial summary
In our study, we aimed to investigate how whole blood viscosity (WBV) affects the development of contrast-induced nephropathy (CIN) in patients undergoing percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Percutaneous Coronary Intervention Patients
- What is being tested?
- Blood Viscosity Testing
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2017to 30 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study started with the approval of the local ethics committee. Five hundred patients between ages 18 and 90 who underwent PCI in our hospital between July 10, 2017, and October 31, 2017, were prospectively included. Informed consent forms were obtained from the patients. Patients with chronic kidney disease (CKD) who underwent hemodialysis or peritoneal dialysis for this reason and patients who underwent to coronary bypass surgery within 48 h were excluded from the study.
Who may be able to join
- patients between ages 18 and 90
- underwent PCI in our hospital between
Who cannot join
- Patients with chronic kidney disease (CKD) who underwent hemodialysis or peritoneal dialysis
- Patients who underwent to coronary bypass surgery within 48 h were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yüksek İhtisas Hastanesi
Bursa, None Selected, 16320
About this study
Official title: The Effect of Whole Blood Viscosity on Contrast-Induced Nephropathy Development in Patients Undergoing Elective Percutaneous Coronary Intervention
In our study, we aimed to investigate how whole blood viscosity (WBV) affects the development of contrast-induced nephropathy (CIN) in patients undergoing percutaneous coronary intervention (PCI).
Read the detailed description
In our study, 500 patients who applied to the cardiology clinic and underwent PCI for elective procedure, ST segment elevation myocardial infarction (STEMI), and non-STEMI were prospectively included. Before the procedure, we calculated WBV using the formula [(0.12 × hematocrit) + (0.17 × (total protein - 2.07)]. We defined CIN as the absolute (≥0.5 mg/dl) or relative increase (≥25%) in serum creatinine 48-72 h after exposure to a contrast agent compared with baseline serum creatinine values.
- Being tested
- Blood Viscosity Testing
- Keywords
- Viscosity, Contrast, Nephropathy, Coronary Intervention
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Viscosity TestingOther
we calculated WBV using the formula [(0.12 × hematocrit) + (0.17 × (total protein - 2.07)]. We defined CIN as the absolute (≥0.5 mg/dl) or relative increase (≥25%) in serum creatinine 48-72 h after exposure to a contrast agent compared with baseline serum creatinine values.
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast Induced Nephropathy
CIN was defined as an increase in serum creatinine levels greater than 0.5 mg/dl or 25% or more increase compared to basal serum creatinine levels 48 to 72 h after exposure.
Measured: 48 to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start10 Jul 2017
- Primary completion31 Oct 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary Intervention PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Postgraduate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ARI, Bursa Postgraduate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703049
- Sponsor's protocol ID
- YİEAH
- Status last verified
- Aug 2021
- First submitted
- 7 Jan 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Camci S, Kinik M, Ari S, Ari H, Melek M, Bozat T. The predictive value of hemoglobin to creatinine ratio for contrast-induced nephropathy in percutaneous coronary interventions. Clin Chem Lab Med. 2022 Jun 22;60(9):1455-1462. doi: 10.1515/cclm-2022-0247. Print 2022 Aug 26.
PubMed 35727209Kinik M, Camci S, Ari S, Ari H, Melek M, Bozat T. The effect of whole blood viscosity on contrast-induced nephropathy development in patients undergoing percutaneous coronary intervention. Postgrad Med. 2022 Jan;134(1):78-84. doi: 10.1080/00325481.2021.1997007. Epub 2021 Nov 10.
PubMed 34670475
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole Blood Viscosity on Contrast-Induced Nephropathy Development in Patients Undergoing Elective Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04703049
- Acronym / sponsor ID
- YİEAH
- Keywords
- Viscosity, Contrast, Nephropathy, Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Bursa Postgraduate HospitalUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In our study, we aimed to investigate how whole blood viscosity (WBV) affects the development of contrast-induced nephropathy (CIN) in patients undergoing percutaneous coronary intervention (PCI).
Detailed description
In our study, 500 patients who applied to the cardiology clinic and underwent PCI for elective procedure, ST segment elevation myocardial infarction (STEMI), and non-STEMI were prospectively included. Before the procedure, we calculated WBV using the formula [(0.12 × hematocrit) + (0.17 × (total protein - 2.07)]. We defined CIN as the absolute (≥0.5 mg/dl) or relative increase (≥25%) in serum creatinine 48-72 h after exposure to a contrast agent compared with baseline serum creatinine values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study started with the approval of the local ethics committee. Five hundred patients between ages 18 and 90 who underwent PCI in our hospital between July 10, 2017, and October 31, 2017, were prospectively included. Informed consent forms were obtained from the patients. Patients with chronic kidney disease (CKD) who underwent hemodialysis or peritoneal dialysis for this reason and patients who underwent to coronary bypass surgery within 48 h were excluded from the study.
Key inclusion criteria (2 listed)
- patients between ages 18 and 90
- underwent PCI in our hospital between
Key exclusion criteria (2 listed)
- Patients with chronic kidney disease (CKD) who underwent hemodialysis or peritoneal dialysis
- Patients who underwent to coronary bypass surgery within 48 h were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Viscosity Testingwe calculated WBV using the formula [(0.12 × hematocrit) + (0.17 × (total protein - 2.07)]. We defined CIN as the absolute (≥0.5 mg/dl) or relative increase (≥25%) in serum creatinine 48-72 h after exposure to a contrast agent compared with baseline serum creatinine values. | Other | – |
Primary outcome
Contrast Induced Nephropathy
Time frame: 48 to 72 hours
CIN was defined as an increase in serum creatinine levels greater than 0.5 mg/dl or 25% or more increase compared to basal serum creatinine levels 48 to 72 h after exposure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Derived from this study: PubMed 35727209Camci S, Kinik M, Ari S, Ari H, Melek M, Bozat T. The predictive value of hemoglobin to creatinine ratio for contrast-induced nephropathy in percutaneous coronary interventions. Clin Chem Lab Med. 2022 Jun 22;60(9):1455-1462. doi: 10.1515/cclm-2022-0247. Print 2022 Aug 26.
- Derived from this study: PubMed 34670475Kinik M, Camci S, Ari S, Ari H, Melek M, Bozat T. The effect of whole blood viscosity on contrast-induced nephropathy development in patients undergoing percutaneous coronary intervention. Postgrad Med. 2022 Jan;134(1):78-84. doi: 10.1080/00325481.2021.1997007. Epub 2021 Nov 10.
- Individual participant dataSharing planned: No
Related trials for Percutaneous Coronary Intervention Patients
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
RecruitingPhase 3
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Coronary Intervention Patients, run by Bursa Postgraduate Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast Induced Nephropathy (time frame: 48 to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04703049, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.