Clinical trial NCT04974814: Effect of Statin Preloading in STEMI in Improving PCI Outcomes
Official title: Comparison of the Treatment Efficacy of Rosuvastatin Versus Atorvastatin Loading Prior to Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Keywords: STEMI
statin
PCI
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The clinical study will be a prospective open label randomized controlled trial
Primary purpose: TREATMENT

Brief summary: To compare the effect of a single high dose of atorvastatin versus rosuvastatin preloading on microvascular coronary perfusion as determined by CTFC in patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI.

Detailed description: Acute myocardial infarction (MI) indicates irreversible myocardial injury resulting in necrosis of a significant portion of myocardium which is caused mostly by coronary plaque rupture or erosion. It could result in several clinical complications and impact cardiac prognosis .

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.

Eligibility criteria: Inclusion Criteria:

* The Presence of symptoms (\<12h).
* 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:

* Previous (within 3 months) or current treatment with statins.
* 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.

Primary outcomes:
measure: angiographic parameters
timeFrame: 3 months
measure: STR (ST-segment resolution) (STR)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Heart Institute
Study officials:
affiliation: National Heart Institute
name: Esraa M Adel, bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beni-Suef University
name: Ahmed A El berry, phd
role: STUDY_DIRECTOR
affiliation: Beni-Suef University
name: Raghda R Hussein, phd
role: STUDY_DIRECTOR
affiliation: National Heart Institute
name: Ahmed A Abd el hamid
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.