Effect of Statin Preloading in STEMI in Improving PCI Outcomes
NCT ID: NCT04974814
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
99 participants
INTERVENTIONAL
2021-05-26
2023-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison Between the Effects of High Doses Statin on Ventricular Remodeling in STEMI Patients
NCT05895123
The Clinical Effect of Intensive Statin Therapy in STEMI Patients Before Emergency PCI
NCT01334671
Effect of Upstream Treatment With High Intensity Statin on the Outcomes of STMI Patients Treated With PPCI
NCT04754789
Effectiveness of Statins on Lipid Goal Attainment and Lipid Parameters in PCI Patients
NCT02561845
Evaluation of the Effect of Long-term Lipid-lowering Therapy in STEMI Patients With Coronavirus Infection COVID-19
NCT04900155
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Worldwide, ischemic heart disease is the single most common cause of death and its frequency is increasing, now Accounts for almost 1.8 million annual deaths.
Cholesterol reduction with HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase inhibitors or statins has been shown to improve mortality and cardiovascular morbidity in patients with established coronary artery disease (CAD).
Previous evidence suggests that statins have various favorable effects on vascular system that are not directly related to their impact on lipid metabolism. Beyond lowering lipids, statins have favorable effects on platelet adhesion, thrombosis, endothelial function, plaque stability, and inflammation. . As with ACS, the vascular injury from coronary angioplasty and stent placement induces platelet activation, thrombosis, and inflammation within the vessel wall and the distal microvasculature. Therefore, in addition to a long-term benefit associated with lipid lowering, statin therapy might play a beneficial role early after PCI.
Conventional TIMI flow grading (Thrombolysis In Myocardial Infarction) is a predictor of cardiac outcome after acute myocardial infarction and PCI, but it has several limitations.
The CTFC (corrected TIMI frame count) another approach to grade flow impairment, is an objective, quantitative, reproducible, and sensitive index for coronary blood flow\[9\].
TIMI flow may appear normal visually, but may correlate to abnormal CTFC. The CTFC has been proposed to have incremental prognostic accuracy in predicting survival outcome with reperfusion therapy . Higher CTFC values after PCI have also been found to be associated with poor clinical outcomes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
control group
in this group patients will not receive statin before primary PCI
Control Test
patients in control arm will not preloaded with statin in ER before PCI
atorvastatin group
in this group patients will receive 80 mg atorvastatin single dose before primary PCI
Atorvastatin 80mg
patients in active arms will be preloaded with a single 80 mg atorvastatin in ER before PCI
rosuvastatin group
in this group patients will receive 40 mg rosuvastatin single dose before primary PCI
Rosuvastatin 40mg
patients in active arms will be preloaded with a single 40 mg rosuvastatin in ER before PCI
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rosuvastatin 40mg
patients in active arms will be preloaded with a single 40 mg rosuvastatin in ER before PCI
Atorvastatin 80mg
patients in active arms will be preloaded with a single 80 mg atorvastatin in ER before PCI
Control Test
patients in control arm will not preloaded with statin in ER before PCI
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ST-segment elevation of at least 0.1Mv in two contiguous leads of electrocardiogram or new onset left bundle branch block.
* Patients age 18 to 80 years.
Exclusion Criteria
* Known allergy to heparin, aspirin, clopidogrel, or abciximab.
* Active severe bleeding.
* Pregnancy.
* History of major surgery or trauma.
* Significant gastrointestinal or genitourinary bleeding (\<6 weeks).
* History of cerebrovascular attack (within 2 years) or cerebrovascular attack with a significant residual neurological deficit.
* Cardiogenic shock with mechanical ventilation.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beni-Suef University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Esraa M. Adel
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Esraa M Adel, bachelor
Role: PRINCIPAL_INVESTIGATOR
National Heart Institute
Ahmed A El berry, phd
Role: STUDY_DIRECTOR
Beni-Suef University
Raghda R Hussein, phd
Role: STUDY_DIRECTOR
Beni-Suef University
Ahmed A Abd el hamid
Role: STUDY_DIRECTOR
National Heart Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Heart Institute
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Elserafy AS, Farag NM, El Desoky AI, Eletriby KA. Effect of high-intensity statin preloading on TIMI flow in patients presenting with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Egypt Heart J. 2020 Jul 10;72(1):40. doi: 10.1186/s43044-020-00074-0.
Jang Y, Zhu J, Ge J, Kim YJ, Ji C, Lam W. Preloading with atorvastatin before percutaneous coronary intervention in statin-naive Asian patients with non-ST elevation acute coronary syndromes: A randomized study. J Cardiol. 2014 May;63(5):335-43. doi: 10.1016/j.jjcc.2013.09.012. Epub 2013 Nov 9.
Ma M, Bu L, Shi L, Guo R, Yang B, Cao H, Luo L, Lu L. Effect of loading dose of atorvastatin therapy prior to percutaneous coronary intervention in patients with acute coronary syndrome: a meta-analysis of six randomized controlled trials. Drug Des Devel Ther. 2019 Apr 16;13:1233-1240. doi: 10.2147/DDDT.S196588. eCollection 2019.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
statin in STEMI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.