Coronary Artery Disease, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction
Conditions
Keywords
Coronary Artery Disease, Myocardial Infarction, Percutaneous Coronary Intervention
Brief summary
Recent guidelines for the management of ST-elevation myocardial infarction (STEMI) recommend against the routine use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) (Class III indication). Yet, so far, there is limited data regarding its role STEMI patients with heavy thrombus burden (TB). The aim of this trial is to evaluate the effects of manual TA and PCI in comparison to conventional PCI alone in a real-life clinical trial among heavy TB STEMI patients undergoing PPCI.
Detailed description
Recent guidelines for the management of ST-elevation myocardial infarction (STEMI) recommend against the routine use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) (Class III indication). Yet, so far, there is limited data regarding its role in STEMI patients with heavy thrombus burden (TB). The aim of this trial is to evaluate the effects of manual TA and PCI in comparison to conventional PCI alone in a real-life clinical trial among heavy TB STEMI patients undergoing PPCI.
Interventions
PROCEDUREManual Thrombus Aspiration
Manual thrombus aspiration using one of the FDA approved aspirators will be done.
PROCEDUREStandard PCI
Standard PCI according to the most recent guidelines
Sponsors
The Young Investigator Group of Cardiovascular Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* STEMI patients with heavy thrombus burden as assessed by TIMI score of 0-1 or thrombus burden classification 4-5
Exclusion criteria
* STEMI patients with low thrombus burden (TIMI 2-3 or TB 0-3) * History of hypersensitivity or allergy to any of the study drugs, as well as known or suspected contraindications to the study drugs. * Symptomatic hypotension and/or an SBP \< 100 mmHg at the time of randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic results | immediately after procedure | Successful revascularization assessed by TIMI flow |
| In-hospital Major adverse cerebrovascular and cardiovascular events (MACCE) | 10 days | Incidence of any major adverse cerebrovascular and cardiovascular events which includes: death (either all-cause or cardiac), nonfatal myocardial infarction, stroke and revascularization (with optional additional specification of target vessel or lesion, i.e., if the revascularization occurred at the site of a previously identified diseased coronary vessel or atherosclerotic lesion, respectively) |
| Short term Major adverse cerebrovascular and cardiovascular events (MACCE) | 6 months | Incidence of any major adverse cerebrovascular and cardiovascular events which includes: death (either all-cause or cardiac), nonfatal myocardial infarction, stroke and revascularization (with optional additional specification of target vessel or lesion, i.e., if the revascularization occurred at the site of a previously identified diseased coronary vessel or atherosclerotic lesion, respectively) in the period of 6 months after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of any bleeding event (Safety outcomes) | 10 days | Incidence of any bleeding event that may be encountered during the hospital stay after randomization. (Major or Minor) |
| In-Hospital Heart failure status | 10 days | Incidence of any event of heart failure that may be encountered during the hospital stay after randomization. |
| Short term Hospitalization due to heart failure | 6 months | Incidence of any event of heart failure that may be encountered during any other re-admission due to a heart failure diagnosis up to 6 months after randomization. |
Countries
Egypt
Outcome results
None listed