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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

alzahraa gamal, master contact

01026181748

alzahraagamal@gmail.com

hatem abdel elrahman contact

01005212162

Hatem19652006@yahoo.com

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

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.

  1. 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)
  1. 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

  2. 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.

  1. First posted8 Apr 2021
  2. Study startApr 2021 (estimated)
  3. Primary completionApr 2022 (estimated)
  4. Study completionApr 2022 (estimated)

Resources

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)
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

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.

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