Effect of Statin Preloading in STEMI in Improving PCI Outcomes

July 19, 2022 updated by: Esraa M. Adel, Beni-Suef University

Comparison of the Treatment Efficacy of Rosuvastatin Versus Atorvastatin Loading Prior to Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 12651
        • Recruiting
        • National Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
in this group patients will not receive statin before primary PCI
Drug: Control Test
patients in control arm will not preloaded with statin in ER before PCI
Active Comparator: atorvastatin group
in this group patients will receive 80 mg atorvastatin single dose before primary PCI
Drug: Atorvastatin 80mg
patients in active arms will be preloaded with a single 80 mg atorvastatin in ER before PCI
Active Comparator: rosuvastatin group
in this group patients will receive 40 mg rosuvastatin single dose before primary PCI
Drug: Rosuvastatin 40mg
patients in active arms will be preloaded with a single 40 mg rosuvastatin in ER before PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
angiographic parameters
Time Frame: 3 months
CTFC (corrected TIMI frame count) In the CTFC method, the number of frames required for dye to reach a standardized distal landmark is counted. A correction factor is required to compensate for the longer length of the left anterior descending artery (LAD) compared with the circumflex and right coronary arteries (the number of frames required for dye to traverse the LAD is divided by 1.7). The frame count number after adjustment for vessel length is given the term 'corrected TIMI frame count'.
3 months
STR (ST-segment resolution) (STR)
Time Frame: 3 months
ST-segment resolution (STR) was calculated as the sum of ST-segment elevation on initial ECG minus the sum of ST-segment elevation on the ECG at 90 min after PCI, divided by the sum of ST- segment elevation on initial ECG, and was expressed as a percentage . The complete early STR was defined as more than or equal to 70% STR.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Esraa M Adel, bachelor, National Heart Institute
  • Study Director: Ahmed A El berry, phd, Beni-Suef University
  • Study Director: Raghda R Hussein, phd, Beni-Suef University
  • Study Director: Ahmed A Abd el hamid, National Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • statin in STEMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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