Acute Myocardial Infarction (AMI)NCT04835207
Metabolic Profile as a Predictor of No-reflow in Diabetic Patients
An observational study of Acute Myocardial Infarction (AMI), run by El Zahraa Gamal.
Trial summary
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 age
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- 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
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Apr 2022
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: diabetic patients with STEMI treated with primary PCI
Who may be able to join
- diabetic patients with ST- elevation myocardial infarction (STEMI ) treated with primary Percutaneous Coronary Intervention ( PCI ) .
Who cannot join
- diabetic patients with ST- elevation myocardial infarction (STEMI ) treated with primary Percutaneous Coronary Intervention ( PCI ) : but have
- (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 ) .
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 .
Many of the well-accepted risk factors for no-reflow are similar to other well-accepted cardiovascular risk factors, such as hypertension, smoking, dyslipidemia, diabetes, and other inflammatory processes. As such, there are some generally accepted measures associated with a lower incidence of no-reflow following PCI for STEMI. For example, in patients with diabetes, optimal blood sugar control before the procedure can reduce the occurrence of no-reflow .
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 . .
Hyperglycemia is associated with The increased mortality in patients with acute myocardial infarction which caused by a larger infarct size, a high incidence of congestive heart failure, and cardiogenic shock, and death after AMI., . However, the underlying mechanisms of these deleterious effects of hyperglycemia are not well understood Uric acid (UA) is a byproduct the terminal steps of purine catabolism, . uric acid synthesis is increased under tissue ischemia. Therefore, elevated uric acid may affect prognosis of (AMI). A few studies have doucomented that UA is associated with therapeutic results in patients with AMI. UA level is appeared to be related to infarct size and hemodynamic derangement. Although prompt restoration of myocardial blood flow is very important for patients with AMI, high levels of UA are doucoumented to be significantly associated with the presence of slow coronary flow
- Conditions
- Acute Myocardial Infarction (AMI)
- 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
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- SOther
Blood 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- S
What is being measured
The primary outcome is the main question the study is designed to answer.
detection correlation between DM and no-reflow phenomenon
measurment of random blood sugar in diabetic patients treated with primary Percutaneous Coronary Intervention ( PCI ) .and show its effects on reflow
Measured: baseline
Secondary outcomes (2)
detection correlation between other metabolic factors as serum uric acid and no-reflow phenomenon
Blood samples were obtained before PCI, and the following parameters will be measured :Serum Uric acid : S .UA
Measured: baseline
detection correlation between other metabolic factors as LDL\HDL and no-reflow phenomenon
Blood samples were obtained before PCI, and the following parameters will be measured :(LDL\HDL :(low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotei
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 startApr 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 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 Acute Myocardial Infarction (AMI)Studies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- El Zahraa Gamal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, El Zahraa Gamal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835207
- Sponsor's protocol ID
- primary ( PCI )
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 8 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 8 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
- NCT04835207
- Acronym / sponsor ID
- primary ( PCI )
- Conditions
- Acute Myocardial Infarction (AMI)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- El Zahraa GamalUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 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.
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 .
Many of the well-accepted risk factors for no-reflow are similar to other well-accepted cardiovascular risk factors, such as hypertension, smoking, dyslipidemia, diabetes, and other inflammatory processes. As such, there are some generally accepted measures associated with a lower incidence of no-reflow following PCI for STEMI. For example, in patients with diabetes, optimal blood sugar control before the procedure can reduce the occurrence of no-reflow .
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 . .
Hyperglycemia is associated with The increased mortality in patients with acute myocardial infarction which caused by a larger infarct size, a high incidence of congestive heart failure, and cardiogenic shock, and death after AMI., . However, the underlying mechanisms of these deleterious effects of hyperglycemia are not well understood Uric acid (UA) is a byproduct the terminal steps of purine catabolism, . uric acid synthesis is increased under tissue ischemia. Therefore, elevated uric acid may affect prognosis of (AMI). A few studies have doucomented that UA is associated with therapeutic results in patients with AMI. UA level is appeared to be related to infarct size and hemodynamic derangement. Although prompt restoration of myocardial blood flow is very important for patients with AMI, high levels of UA are doucoumented to be significantly associated with the presence of slow coronary flow
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- diabetic patients with STEMI treated with primary PCI
Key inclusion criteria (1 listed)
- diabetic patients with ST- elevation myocardial infarction (STEMI ) treated with primary Percutaneous Coronary Intervention ( PCI ) .
Key exclusion criteria (4 listed)
- diabetic patients with ST- elevation myocardial infarction (STEMI ) treated with primary Percutaneous Coronary Intervention ( PCI ) : but have
- (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- S | Other | – |
Primary outcome
detection correlation between DM and no-reflow phenomenon
Time frame: baseline
measurment of random blood sugar in diabetic patients treated with primary Percutaneous Coronary Intervention ( PCI ) .and show its effects on reflow
2 secondary outcomes
detection correlation between other metabolic factors as serum uric acid and no-reflow phenomenon
Time frame: baseline
detection correlation between other metabolic factors as LDL\HDL and no-reflow phenomenon
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 8 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.
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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?
An observational study of Acute Myocardial Infarction (AMI), run by El Zahraa Gamal.
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 8 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?
detection correlation between DM and no-reflow phenomenon (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 NCT04835207, 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 8 Apr 2021.