No-Reflow PhenomenonNCT04835974
the No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI)
A study testing 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S in people with No-Reflow Phenomenon, run by Assiut University.
Trial summary
1- to find metabolic factors that correlate with the development of no reflow phenomenon that may help prevent its occurrence . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- No-Reflow Phenomenon
- What is being tested?
- 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to May 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- diabetic patients with STEMI treated with primary PCI
Who cannot join
- non diabetic . with selected PCI
- (1) a history of an unprotected left main artery with severe liver and kidney diseases or coronary artery bypass grafting .
- patients who had valvular disease or cardiomyopathy . (3) severe dissection, thromboembolism in other parts, or vasospasm; and known malignancy .
- patients with contraindications for anticoagulant therapy, such as active visceral hemorrhage, hemorrhagic stroke, or ischemic stroke within half a year (including transient ischemic attack), or aortic dissection, or patients with hematological diseases complicated with coagulation disorders .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Metabolic Profile as a Predictor of No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI)
1- to find metabolic factors that correlate with the development of no reflow phenomenon that may help prevent its occurrence .
Read the detailed description
Acute myocardial infarction (AMI) with its accompanying adverse sequelae is one of the most common causes of morbidity and mortality in the world .
Although reperfusion techniques for ST- elevation myocardial infarction (STEMI ) are constantly improving, no-reflow can still lead to poor prognosis .
At present, the exact mechanism of no-reflow remains unclear, but clinical and laboratory findings suggest that it is related to the embolism of the capillary bed, ischemic injury, vascular endothelial dysfunction, production of oxygen free radical , and other factors .
The no-reflow phenomenon is one of complications of poor functional and clinical outcomes for patients with (AMI) .
The no-reflow phenomenon is present in 25% to 30% of patients with (AMI) underwent successful coronary recanalization, as shown by angiography . The myocardial no-reflow phenomenon is associated with a reducution of antegrade myocardial blood flow inspite of an open infarct-related artery in patients with (STEMI ) undergoing (PCI). Importantly, no-reflow is known to be related to unfavorable clinical outcome and prognosis . The cause of this complex phenomenon is the variable combination of four pathogenetic components: distal atherothrombotic embolization, ischemic injury, reperfusion injury and susceptibility of coronary microcirculation to injury . As a consequence, appropriate strategies are expected to prevent or treat these components are expected to avoid the no-reflow. Coronary reperfusion therapy is widely performed in patients with (AMI) . However, in spite of patency of the infarct-related artery , there is no guarantee of salvage of myocardium at risk of ischemia .The no-reflow phenomenon is found in >30% of patients after thrombolysis or catheter-based (PCI) for (AMI) . It is important, therefore, to be able to predict which lesions are high risk for no reflow before beginning PCI .
There are numerous recognized risk factors for the development of coronary artery disease (CAD), one of the best known is the association between blood lipids and CAD . Several prospective studies have established that the risk of cardiac morbidity and mortality is directly related to the concentration of plasma cholesterol. ' The most prevalent view is that the increased risk of myocardial infarction associated with elevated plasma cholesterol levels can be adequately explained on the basis of the increase in number and severity of coronary atherosclerotic vascular lesions . .
- Conditions
- No-Reflow Phenomenon
- Being tested
- 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S
- Medical subject headings
- No-Reflow Phenomenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- SDiagnostic test
Blood samples were obtained before PCI, and the following parameters will be measured:
- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio.
- Glycemia will be assessed : RBS ( random blood sugar ) .
- Serum Uric acid : S .UA
| Study group | Role | What they receive |
|---|---|---|
| diabetic patients with reflow phenomenon | Experimental | All Assiut University heart Hospital patients ,and who meet the listed inclusion and exclusion criteria will be eligible for the study. Patients' charts will be retrieved based on their intervention procedures. The charts will be reviewed and eligible patients will be filtered. The needed variables will be entered into our data base for later data analysis. Receives: Diagnostic Test: 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure serum random blood sugar
to detect the correlation between the diabetus mellitus (serum random blood sugar) and no-reflow phenomenon and analysis of this metabolic factors in patient withSTEMI who will undergo primaru PCI and show its effects on no-reflow phenomenon that may help prevent its occurrence .
Measured: baseline
Secondary outcomes (2)
measure the serum uric acid
to detect the correlation between the serum uric acid , lipid profile and no-reflow phenomenon and show other metabolic factors effects on no-reflow to avoid its occurance
Measured: baseline
measure the lipid profile
to detect the correlation between lipid profile and no-reflow phenomenon
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for No-Reflow PhenomenonStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El Zahraa Gamal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835974
- Sponsor's protocol ID
- No-reflow phenomenon
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bernstein JM, Lee J, Conboy K, Ellis E, Li P. The role of IgE mediated hypersensitivity in recurrent otitis media with effusion. Am J Otol. 1983 Jul;5(1):66-9. No abstract available.
PubMed 6683937
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Profile as a Predictor of No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT04835974
- Acronym / sponsor ID
- No-reflow phenomenon
- Conditions
- No-Reflow Phenomenon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 8 Apr 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.
1- to find metabolic factors that correlate with the development of no reflow phenomenon that may help prevent its occurrence .
Detailed description
Acute myocardial infarction (AMI) with its accompanying adverse sequelae is one of the most common causes of morbidity and mortality in the world .
Although reperfusion techniques for ST- elevation myocardial infarction (STEMI ) are constantly improving, no-reflow can still lead to poor prognosis .
At present, the exact mechanism of no-reflow remains unclear, but clinical and laboratory findings suggest that it is related to the embolism of the capillary bed, ischemic injury, vascular endothelial dysfunction, production of oxygen free radical , and other factors .
The no-reflow phenomenon is one of complications of poor functional and clinical outcomes for patients with (AMI) .
The no-reflow phenomenon is present in 25% to 30% of patients with (AMI) underwent successful coronary recanalization, as shown by angiography . The myocardial no-reflow phenomenon is associated with a reducution of antegrade myocardial blood flow inspite of an open infarct-related artery in patients with (STEMI ) undergoing (PCI). Importantly, no-reflow is known to be related to unfavorable clinical outcome and prognosis . The cause of this complex phenomenon is the variable combination of four pathogenetic components: distal atherothrombotic embolization, ischemic injury, reperfusion injury and susceptibility of coronary microcirculation to injury . As a consequence, appropriate strategies are expected to prevent or treat these components are expected to avoid the no-reflow. Coronary reperfusion therapy is widely performed in patients with (AMI) . However, in spite of patency of the infarct-related artery , there is no guarantee of salvage of myocardium at risk of ischemia .The no-reflow phenomenon is found in >30% of patients after thrombolysis or catheter-based (PCI) for (AMI) . It is important, therefore, to be able to predict which lesions are high risk for no reflow before beginning PCI .
There are numerous recognized risk factors for the development of coronary artery disease (CAD), one of the best known is the association between blood lipids and CAD . Several prospective studies have established that the risk of cardiac morbidity and mortality is directly related to the concentration of plasma cholesterol. ' The most prevalent view is that the increased risk of myocardial infarction associated with elevated plasma cholesterol levels can be adequately explained on the basis of the increase in number and severity of coronary atherosclerotic vascular lesions . .
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic patients with reflow phenomenon | Experimental | Diagnostic Test: 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- SAll Assiut University heart Hospital patients ,and who meet the listed inclusion and exclusion criteria will be eligible for the study. Patients' charts will be retrieved based on their intervention procedures. The charts will be reviewed and eligible patients will be filtered. The needed variables will be entered into our data base for later data analysis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diabetic patients with STEMI treated with primary PCI
Key exclusion criteria (4 listed)
- non diabetic . with selected PCI
- (1) a history of an unprotected left main artery with severe liver and kidney diseases or coronary artery bypass grafting .
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 |
|---|---|---|
| 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- SBlood samples were obtained before PCI, and the following parameters will be measured: 1. LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2. Glycemia will be assessed : RBS ( random blood sugar ) . 3. Serum Uric acid : S .UA | Diagnostic test | diabetic patients with reflow phenomenon |
Primary outcome
measure serum random blood sugar
Time frame: baseline
to detect the correlation between the diabetus mellitus (serum random blood sugar) and no-reflow phenomenon and analysis of this metabolic factors in patient withSTEMI who will undergo primaru PCI and show its effects on no-reflow phenomenon that may help prevent its occurrence .
2 secondary outcomes
measure the serum uric acid
Time frame: baseline
measure the lipid profile
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Background: PubMed 6683937Bernstein JM, Lee J, Conboy K, Ellis E, Li P. The role of IgE mediated hypersensitivity in recurrent otitis media with effusion. Am J Otol. 1983 Jul;5(1):66-9. No abstract available.
Related trials for No-Reflow Phenomenon
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RecruitingPhase 4
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No-Reflow Phenomenon, Coronary Artery Disease
Not yet recruitingObservational study
Insulin Resistance and Its Association With no Reflow Phenomenon After Primary PCI in Type II Diabetic STEMI Patients.
STEMI, No-Reflow Phenomenon
RecruitingPhase 4
Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention
ST-Segment Elevation Myocardial Infarction (STEMI), No-Reflow Phenomenon
RecruitingObservational study
Investigation of Brain Blood Flow Changes in Acute Ischemic Stroke Patients After Successful Endovascular Thrombectomy
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S in people with No-Reflow Phenomenon, run by Assiut University.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact alzahraa gamal, master (01026181748, alzahraagamal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure serum random blood sugar (time frame: baseline). 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 NCT04835974, which also lists 1 linked publication.
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 14 Apr 2021.