Contrast-Induced NephropathyACEI-RFNCT07184918
Effect of Continuing vs. Discontinuing ACE Inhibitors on Renal Function After Coronary Angiography
A study testing Continuing Ramipril and Withholding Ramipril in people with Contrast-Induced Nephropathy and Coronary Angiography, run by Tanta University at 1 site in Egypt.
Trial summary
This clinical trial evaluates whether continuing or withholding ACE inhibitors (specifically Ramipril) before coronary angiography affects the risk of contrast-induced nephropathy (CIN). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Contrast-Induced Nephropathy, Coronary Angiography, Acute Kidney Injury
- What is being tested?
- Continuing Ramipril and Withholding Ramipril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Jun 2025
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) scheduled for elective coronary angiography
- Currently on ACE inhibitor (Ramipril)
- Serum creatinine ≤1.5 mg/dL
Who cannot join
- STEMI within last 2 weeks
- NYHA Class IV heart failure
- CrCl <50 mL/min
- Serum potassium >5.0 mEq/L
- Recent contrast exposure
- Pregnancy or breastfeeding
- Cardiogenic shock or sepsis
- Severe uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Pharmacy Tanta university
Tanta, Gharbia Governorate, 31527
About this study
Official title: Clinical Study Evaluating the Effect of Continuing or Discontinuing Angiotensin-Converting Enzyme Inhibitor on Renal Function in Patients Undergoing Coronary Angiography
This clinical trial evaluates whether continuing or withholding ACE inhibitors (specifically Ramipril) before coronary angiography affects the risk of contrast-induced nephropathy (CIN). CIN is a known complication of iodinated contrast exposure, particularly in patients with chronic conditions such as hypertension or diabetes. The trial involves 44 adult patients randomized into two groups: one continuing Ramipril and the other withholding it 48 hours before and restarting 72 hours after the procedure. Renal biomarkers including serum creatinine, NGAL, and superoxide dismutase will be assessed to evaluate renal function.
Read the detailed description
This randomized controlled study is designed to provide clinical evidence on whether withholding ACE inhibitors prior to contrast administration in coronary angiography affects kidney function. Participants are randomized into two arms: one arm will discontinue ACE inhibitors 48 hours prior and restart 72 hours post angiography, while the other will continue therapy without interruption. Primary endpoints include incidence of CIN as defined by a ≥0.5 mg/dL or ≥25% increase in serum creatinine within 72 hours. Secondary endpoints include NGAL, SOD, and potassium levels.
- Being tested
- Continuing Ramipril, Withholding Ramipril
- Keywords
- CIN, Ramipril, Renal Function, Cardiac Catheterization, Nephrotoxicity, Renal Biomarkers
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuing RamiprilDrug
Also called Tritace
Participants in this group will continue taking Ramipril at their usual dose before, during, and after the coronary angiography. The objective is to evaluate the renal effects of uninterrupted ACE inhibitor therapy during contrast exposure.
Withholding RamiprilDrug
Also called Tritace
Participants in this group will stop taking Ramipril 48 hours before the angiography procedure and resume it 72 hours after. This intervention is used to evaluate whether temporarily withholding ACE inhibitors reduces the risk of contrast-induced nephropathy.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Withholding Ramipril | Experimental | Discontinue Ramipril 48 hours prior to coronary angiograph. Receives: Drug: Withholding Ramipril |
| Arm 2: Continuing Ramipril | Active comparator | Continue Ramipril throughout the peri-procedural period. Receives: Drug: Continuing Ramipril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Serum Creatinine at 72 Hours Post-Angiography
CIN defined as ≥0.5 mg/dL or ≥25% rise in serum creatinine from baseline.
Measured: Baseline and 72 hours post-angiography
Secondary outcomes (3)
Change in NGAL and SOD levels (pre vs post)
Change in serum NGAL (Neutrophil Gelatinase-Associated Lipocalin) and SOD (Superoxide Dismutase) levels measured before and 72 hours after coronary angiography. These biomarkers are used to assess early tubular injury and oxidative stress respectively. Comparison will be made between intervention arms to determine whether ACE inhibitor withholding reduces renal cellular stress.
Measured: Baseline and 72 hours post-angiography
Incidence of Hyperkalemia After Coronary Angiography
Proportion of participants who develop hyperkalemia (defined as serum potassium >5.5 mmol/L) within 72 hours after coronary angiography. Comparison will be made between participants who continued ACE inhibitor therapy and those who withheld it to evaluate the impact of ACEI on electrolyte disturbance.
Measured: Within 72 hours post-angiography
Incidence of Clinical Adverse Events Within 72 Hours
Occurrence of adverse clinical outcomes including dialysis requirement, myocardial infarction, stroke, or new-onset heart failure within 72 hours of coronary angiography. Events will be monitored and compared between the two intervention groups to evaluate safety related to ACE inhibitor continuation or withholding.
Measured: Within 72 hours post-angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Feb 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-Induced NephropathyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Magdy Ali Mohamed Radwan, Tanta University
- Investigators
- Dalia R El-Afify, Assoc Prof, Study chair, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184918
- Sponsor's protocol ID
- ACEI-RF-2024
- Acronym
- ACEI-RF
- Status last verified
- Sep 2025
- First submitted
- 13 Jun 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected in this study are part of a Master's thesis conducted at Tanta University. There is currently no plan to share individual participant data (IPD) due to institutional academic policies and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Effect of Continuing or Discontinuing Angiotensin-Converting Enzyme Inhibitor on Renal Function in Patients Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT07184918
- Acronym / sponsor ID
- ACEI-RF / ACEI-RF-2024
- Keywords
- CIN, Ramipril, Renal Function, Cardiac Catheterization, Nephrotoxicity, Renal Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 22 Sep 2025 (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.
This clinical trial evaluates whether continuing or withholding ACE inhibitors (specifically Ramipril) before coronary angiography affects the risk of contrast-induced nephropathy (CIN). CIN is a known complication of iodinated contrast exposure, particularly in patients with chronic conditions such as hypertension or diabetes. The trial involves 44 adult patients randomized into two groups: one continuing Ramipril and the other withholding it 48 hours before and restarting 72 hours after the procedure. Renal biomarkers including serum creatinine, NGAL, and superoxide dismutase will be assessed to evaluate renal function.
Detailed description
This randomized controlled study is designed to provide clinical evidence on whether withholding ACE inhibitors prior to contrast administration in coronary angiography affects kidney function. Participants are randomized into two arms: one arm will discontinue ACE inhibitors 48 hours prior and restart 72 hours post angiography, while the other will continue therapy without interruption. Primary endpoints include incidence of CIN as defined by a ≥0.5 mg/dL or ≥25% increase in serum creatinine within 72 hours. Secondary endpoints include NGAL, SOD, and potassium levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Withholding Ramipril | Experimental | Drug: Withholding RamiprilDiscontinue Ramipril 48 hours prior to coronary angiograph. |
| Arm 2: Continuing Ramipril | Active comparator | Drug: Continuing RamiprilContinue Ramipril throughout the peri-procedural period. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years) scheduled for elective coronary angiography
- Currently on ACE inhibitor (Ramipril)
- Serum creatinine ≤1.5 mg/dL
Key exclusion criteria (8 listed)
- STEMI within last 2 weeks
- NYHA Class IV heart failure
- CrCl <50 mL/min
- Serum potassium >5.0 mEq/L
- Recent contrast exposure
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 |
|---|---|---|
| Continuing RamiprilAlso: TritaceParticipants in this group will continue taking Ramipril at their usual dose before, during, and after the coronary angiography. The objective is to evaluate the renal effects of uninterrupted ACE inhibitor therapy during contrast exposure. | Drug | Arm 2: Continuing Ramipril |
| Withholding RamiprilAlso: TritaceParticipants in this group will stop taking Ramipril 48 hours before the angiography procedure and resume it 72 hours after. This intervention is used to evaluate whether temporarily withholding ACE inhibitors reduces the risk of contrast-induced nephropathy. | Drug | Arm 1: Withholding Ramipril |
Primary outcome
Change From Baseline in Serum Creatinine at 72 Hours Post-Angiography
Time frame: Baseline and 72 hours post-angiography
CIN defined as ≥0.5 mg/dL or ≥25% rise in serum creatinine from baseline.
3 secondary outcomes
Change in NGAL and SOD levels (pre vs post)
Time frame: Baseline and 72 hours post-angiography
Incidence of Hyperkalemia After Coronary Angiography
Time frame: Within 72 hours post-angiography
Incidence of Clinical Adverse Events Within 72 Hours
Time frame: Within 72 hours post-angiography
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 22 Sep 2025.
- Individual participant dataSharing planned: No. The data collected in this study are part of a Master's thesis conducted at Tanta University. There is currently no plan to share individual participant data (IPD) due to institutional academic policies and ethical considerations.
Related trials for Contrast-Induced Nephropathy
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruitingObservational study
Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
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An Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT
Contrast-associated Acute Kidney Injury
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Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
Not yet recruitingObservational study
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
Contrast-Associated Acute Kidney Injury, Acute Kidney Injury
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.
Dalia R El-Afify, Assoc Prof study chair
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuing Ramipril and Withholding Ramipril in people with Contrast-Induced Nephropathy and Coronary Angiography, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 8 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 22 Sep 2025. 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 Egypt. 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?
Change From Baseline in Serum Creatinine at 72 Hours Post-Angiography (time frame: Baseline and 72 hours post-angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2025.