Coronary Artery Disease Clinical Trial
— TSUNAMIOfficial title:
Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction: TSUNAMI Trial
Verified date | July 2023 |
Source | The Young Investigator Group of Cardiovascular Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 124 |
Est. completion date | December 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Andalusia Hospitals | Alexandria | |
Egypt | International Cardiac Center (ICC) | Alexandria | |
Egypt | Ain Shams University Hospitals | Cairo | |
Egypt | National Heart Institute | Giza |
Lead Sponsor | Collaborator |
---|---|
The Young Investigator Group of Cardiovascular Research |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Angiographic results | Successful revascularization assessed by TIMI flow | immediately after procedure | |
Primary | Angiographic results | Successful revascularization assessed by myocardial blush. | immediately after procedure | |
Primary | Angiographic results | Successful revascularization assessed by ST-segment resolution. | immediately after procedure | |
Primary | In-hospital Major adverse cerebrovascular and cardiovascular events (MACCE) | 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) | 10 days | |
Primary | Short term Major adverse cerebrovascular and cardiovascular events (MACCE) | 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. | 6 months | |
Secondary | Incidence of any bleeding event (Safety outcomes) | Incidence of any bleeding event that may be encountered during the hospital stay after randomization. (Major or Minor) | 10 days | |
Secondary | In-Hospital Heart failure status | Incidence of any event of heart failure that may be encountered during the hospital stay after randomization. | 10 days | |
Secondary | Short term Hospitalization due to heart failure | 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. | 6 months |
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