Contrast-induced Acute Kidney InjuryPhase 4TRACK-AMINCT03526367
A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of CIAKI in Patient With AMI Undergoing Emergency PCI
A Phase 4 study testing hydration plus rosuvastatin therapy and Standard therapy in people with Contrast-induced Acute Kidney Injury and ST Elevation Myocardial Infarction, run by Shenyang Northern Hospital at 1 site in China.
Trial summary
The CIAKI,as the third complication of PCI, was associated with adverse cardiac events after procedure. Moreover, because the rate of periprocedure hydration is inadequate in STEMI patients before primary PCI, the incidence of CIAKI is higher significantly in these patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Contrast-induced Acute Kidney Injury, ST Elevation Myocardial Infarction, Primary PCI
- What is being tested?
- hydration plus rosuvastatin therapy and Standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2019to 31 Dec 2019
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old
- The STEMI patients within 12 h of onset(or within 12-24 h of onset with chest pain and persistent ST-segment elevation or the presence of a new LBBB);
- The patients planned primary PCI;
- At least one of the following:
- Diabetes mellitus, Chronic Kidney Disease, Female, Elder(Age≥65), Hypertension class 3, Congestive heart failure
- Voluntary signature of informed consent
Who cannot join
- Type 2 Myocardial infarction secondary to an ischaemic imbalance
- Intolerance of statin or iodine contrast
- eGFR<30ml/min
- Administration of any iodinated (e.g.CT angiography) within 14 days before enrollment
- Hepatic dysfunction, ALT 3 times greater than upper normal limit
- Thyreoid insufficiency
Show all 10Show fewer
- Hemodynamic instability
- Have received PCI or CABG within 30 day before enrollment
- Plan to perform any coronary angiography or PCI within 30 days
- Have received any statins within 7 days before enrollment
Trial locations and contacts
1 site in 1 country.
China1 site
The General Hospital of Shenyang Millitary Region
Shenyang, Liaoning
About this study
Official title: A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of Contrast Induced Acute Kidney Injury in Patient With Acute Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention (TRACK-AMI)
The CIAKI,as the third complication of PCI, was associated with adverse cardiac events after procedure. Moreover, because the rate of periprocedure hydration is inadequate in STEMI patients before primary PCI, the incidence of CIAKI is higher significantly in these patients. The cardiovascular pleiotropic effects of statins in addition to lipid have been widely concerned. The previous studies demonstrated usage of statin in periprocedure could decrease the risk of CIAKI. Compared with hydration, the usage of statin to prevention CIAKI show the advantages in clinical practice, for example，there is no need to consider the cardiac function.The optimal strategies for preventting CIAKI in STEMI patients undergoing primary PCI needed further studies to explore. What's more, whether a synergistic effect of hydration and statin or not is unknown.
- Conditions
- Contrast-induced Acute Kidney Injury, ST Elevation Myocardial Infarction, Primary PCI, Rosuvastatin, Hydration
- Being tested
- hydration plus rosuvastatin therapy, Standard therapy
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydration plus rosuvastatin therapyDrug
In experimental group,a loading dose of rosuvastatin 20mg then 10 mg daily followed for at least 7 days and hydration（3ml/kg/h）last 12 hours after randomized
Standard therapyDrug
Prohibition of use any statins from randomized to 12 hours after procedure; The hydration or not is determined by physicians but 1 ml/kg/h at most.
| Study group | Role | What they receive |
|---|---|---|
| hydration plus rosuvastatin therapy | Experimental | 1. After randomized，hydration（3ml/kg/h, if patients had LVEF<40%, 1.5 ml/kg/h）last 12 hours;
2. After randomized，a loading dose of rosuvastatin 20mg then 10 mg daily followed for at least 7 days. Receives: Drug: hydration plus rosuvastatin therapy |
| Standard therapy | Active comparator | No statin within 12 h after randomization, hydration at physicians' discretion, but no more than 1ml/kg/h. Receives: Drug: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIAKI
CIAKI, defined an Absolute Increase in SCr ≥0.5mg/dL（≥44.2μmmol/L）or a ≥ 25% Increase in SCr From Baseline to 7 days After the Procedure
Measured: 7 days
Secondary outcomes (5)
The peak value of Scr
Measured: withtin 7 days before randomized
The rate of Aggravated Heart Function
Aggravated at Least 1 Class of Heart Function
Measured: withtin 30 days before randomized
The rate of Hospitalization for Aggravated Renal Function, Acute Renal Failure, Dialysis or Hemofiltration
Measured: withtin 30 days before randomized
the level of hsCRP
Measured: withtin 7 days before randomized
The Composite of all-cause death, MI, stroke, and TVR
Measured: withtin 30 days before randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start20 Feb 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: Study withdrawn for no sufficient fund support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-induced Acute Kidney InjuryStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
- Investigators
- Yaling Han, MD, Principal investigator, The General Hospital of Shenyang Millitary Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526367
- Sponsor's protocol ID
- TRACK-AMI V1.0
- Acronym
- TRACK-AMI
- Status last verified
- Sep 2019
- First submitted
- 25 Apr 2018
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Rosuvastatin Loading Combined With Early hydrAtion Versus Standard-of-care Medications for the Prevention of Contrast Induced Acute Kidney Injury in Patient With Acute Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention (TRACK-AMI)
- ClinicalTrials.gov ID
- NCT03526367
- Acronym / sponsor ID
- TRACK-AMI / TRACK-AMI V1.0
- Conditions
- Contrast-induced Acute Kidney Injury, ST Elevation Myocardial Infarction, Primary PCI, Rosuvastatin, Hydration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn for no sufficient fund support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 20 Feb 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 16 May 2018 (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.
The CIAKI,as the third complication of PCI, was associated with adverse cardiac events after procedure. Moreover, because the rate of periprocedure hydration is inadequate in STEMI patients before primary PCI, the incidence of CIAKI is higher significantly in these patients. The cardiovascular pleiotropic effects of statins in addition to lipid have been widely concerned. The previous studies demonstrated usage of statin in periprocedure could decrease the risk of CIAKI. Compared with hydration, the usage of statin to prevention CIAKI show the advantages in clinical practice, for example，there is no need to consider the cardiac function.The optimal strategies for preventting CIAKI in STEMI patients undergoing primary PCI needed further studies to explore. What's more, whether a synergistic effect of hydration and statin or not is unknown.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydration plus rosuvastatin therapy | Experimental | Drug: hydration plus rosuvastatin therapy1. After randomized，hydration（3ml/kg/h, if patients had LVEF<40%, 1.5 ml/kg/h）last 12 hours; 2. After randomized，a loading dose of rosuvastatin 20mg then 10 mg daily followed for at least 7 days. |
| Standard therapy | Active comparator | Drug: Standard therapyNo statin within 12 h after randomization, hydration at physicians' discretion, but no more than 1ml/kg/h. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 years old
- The STEMI patients within 12 h of onset(or within 12-24 h of onset with chest pain and persistent ST-segment elevation or the presence of a new LBBB);
- The patients planned primary PCI;
- At least one of the following:
- Diabetes mellitus, Chronic Kidney Disease, Female, Elder(Age≥65), Hypertension class 3, Congestive heart failure
Key exclusion criteria (10 listed)
- Type 2 Myocardial infarction secondary to an ischaemic imbalance
- Intolerance of statin or iodine contrast
- eGFR<30ml/min
- Administration of any iodinated (e.g.CT angiography) within 14 days before enrollment
- Hepatic dysfunction, ALT 3 times greater than upper normal limit
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 |
|---|---|---|
| hydration plus rosuvastatin therapyIn experimental group,a loading dose of rosuvastatin 20mg then 10 mg daily followed for at least 7 days and hydration（3ml/kg/h）last 12 hours after randomized | Drug | hydration plus rosuvastatin therapy |
| Standard therapyProhibition of use any statins from randomized to 12 hours after procedure; The hydration or not is determined by physicians but 1 ml/kg/h at most. | Drug | Standard therapy |
Primary outcome
CIAKI
Time frame: 7 days
CIAKI, defined an Absolute Increase in SCr ≥0.5mg/dL（≥44.2μmmol/L）or a ≥ 25% Increase in SCr From Baseline to 7 days After the Procedure
5 secondary outcomes
The peak value of Scr
Time frame: withtin 7 days before randomized
The rate of Aggravated Heart Function
Time frame: withtin 30 days before randomized
The rate of Hospitalization for Aggravated Renal Function, Acute Renal Failure, Dialysis or Hemofiltration
Time frame: withtin 30 days before randomized
the level of hsCRP
Time frame: withtin 7 days before randomized
The Composite of all-cause death, MI, stroke, and TVR
Time frame: withtin 30 days before randomized
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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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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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.
Yaling Han, MD principal investigator
The General Hospital of Shenyang Millitary Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hydration plus rosuvastatin therapy and Standard therapy in people with Contrast-induced Acute Kidney Injury and ST Elevation Myocardial Infarction, run by Shenyang Northern Hospital at 1 site in China.
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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 19 Sep 2019. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
CIAKI (time frame: 7 days). 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 19 Sep 2019.