Coronary Artery DiseaseTSUNAMINCT04912570
Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction
A study testing Manual Thrombus Aspiration and Standard PCI in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by The Young Investigator Group of Cardiovascular Research at 4 sites in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction
- What is being tested?
- Manual Thrombus Aspiration and Standard PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 4 sitesEgypt
- Study dates
- 1 Jul 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEMI patients with heavy thrombus burden as assessed by TIMI score of 0-1 or thrombus burden classification 4-5
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Egypt4 sites
Andalusia Hospitals
Alexandria, 21521
International Cardiac Center (ICC)
Alexandria, 21524
Ain Shams University Hospitals
Cairo
National Heart Institute
Giza
About this study
Official title: Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction: TSUNAMI Trial
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction
- Being tested
- Manual Thrombus Aspiration, Standard PCI
- Keywords
- Coronary Artery Disease, Myocardial Infarction, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease, ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Thrombus AspirationProcedure or surgery
Also called Thrombus Aspiration
Manual thrombus aspiration using one of the FDA approved aspirators will be done.
Standard PCIProcedure or surgery
Standard PCI according to the most recent guidelines
| Study group | Role | What they receive |
|---|---|---|
| Manual Thrombus Aspiration | Experimental | Manual Thrombus aspiration in STEMI patients with Heavy thrombus burden (TIMI 0-1 or TB classification 4-5) Receives: Procedure: Manual Thrombus Aspiration |
| Standard PCI | Active comparator | Conventional PCI according to the most recent guidelines in STEMI patients with no heavy thrombus burden (TIMI 0-1 or TB classification 4-5) Receives: Procedure: Standard PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic results
Successful revascularization assessed by TIMI flow
Measured: immediately after procedure
Angiographic results
Successful revascularization assessed by myocardial blush.
Measured: immediately after procedure
Angiographic results
Successful revascularization assessed by ST-segment resolution.
Measured: immediately after procedure
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)
Measured: 10 days
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.
Measured: 6 months
Secondary outcomes (3)
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)
Measured: 10 days
In-Hospital Heart failure status
Incidence of any event of heart failure that may be encountered during the hospital stay after randomization.
Measured: 10 days
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Jul 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Why it stopped: No catheters
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Young Investigator Group of Cardiovascular Research
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Haitham Badran, MD, Study chair, Ain Shams UniversityMahmoud H Abdelnabi, MD, Principal investigator, University of Alexandria - EgyptAhmed M El Amrawy, MD, Study director, University of Alexandria - EgyptYasser Sadek, MD, Study director, National Heart Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912570
- Sponsor's protocol ID
- YIG0502101
- Acronym
- TSUNAMI
- Status last verified
- Jul 2023
- First submitted
- 19 May 2021
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction: TSUNAMI Trial
- ClinicalTrials.gov ID
- NCT04912570
- Acronym / sponsor ID
- TSUNAMI / YIG0502101
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction
- Keywords
- Coronary Artery Disease, Myocardial Infarction, Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: No catheters
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- The Young Investigator Group of Cardiovascular ResearchResearch network
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Thrombus Aspiration | Experimental | Procedure: Manual Thrombus AspirationManual Thrombus aspiration in STEMI patients with Heavy thrombus burden (TIMI 0-1 or TB classification 4-5) |
| Standard PCI | Active comparator | Procedure: Standard PCIConventional PCI according to the most recent guidelines in STEMI patients with no heavy thrombus burden (TIMI 0-1 or TB classification 4-5) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- STEMI patients with heavy thrombus burden as assessed by TIMI score of 0-1 or thrombus burden classification 4-5
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Thrombus AspirationAlso: Thrombus AspirationManual thrombus aspiration using one of the FDA approved aspirators will be done. | Procedure or surgery | Manual Thrombus Aspiration |
| Standard PCIStandard PCI according to the most recent guidelines | Procedure or surgery | Standard PCI |
Primary outcome
Angiographic results
Time frame: immediately after procedure
Successful revascularization assessed by TIMI flow
Angiographic results
Time frame: immediately after procedure
Successful revascularization assessed by myocardial blush.
Angiographic results
Time frame: immediately after procedure
Successful revascularization assessed by ST-segment resolution.
In-hospital Major adverse cerebrovascular and cardiovascular events (MACCE)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Incidence of any bleeding event (Safety outcomes)
Time frame: 10 days
In-Hospital Heart failure status
Time frame: 10 days
Short term Hospitalization due to heart failure
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haitham Badran, MD study chair
Ain Shams University
Mahmoud H Abdelnabi, MD principal investigator
University of Alexandria - Egypt
Ahmed M El Amrawy, MD study director
University of Alexandria - Egypt
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Thrombus Aspiration and Standard PCI in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by The Young Investigator Group of Cardiovascular Research at 4 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiographic results (time frame: immediately after procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.