STEMINCT05793671
Follow up of Clinical Outcome of Deferred vs Immediate Stenting in High Thrombus Stemi Patients
A study testing PPCI in heavy thrombus burden STEMI patients in people with STEMI, run by Assiut University.
Trial summary
To compare the effect of immediate stenting versus deferred stenting - with use of glycoproteinIIbIIIa inhibitor \& low molecular weight heparin - on the clinical outcome -3 and 6 months after stenting \& also infarct size using troponin level during hospital stay . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- STEMI
- What is being tested?
- PPCI in heavy thrombus burden STEMI patients
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary percutaneous coronary intervention (PPCI) patients with culprit vessels shows heavy thrombus burden lesions.
- Culprit vessels with TIMI 2-3 either from the beginning or after MIMI (Minimalist immediate mechanical intervention).
Who cannot join
- PPCI patients with low thrombus burden lesions.
- PPCI patient with heavy thrombus burden lesions but with culprit vessels TIMI score 0-1, didn't improve after MIMI.
- patients killip II /III /IV
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Short Term Clinical and Major Cardiovascular Adverse Events of Deferred Versus Immediate Stenting in High Thrombus Burden STEMI Patients
To compare the effect of immediate stenting versus deferred stenting - with use of glycoproteinIIbIIIa inhibitor \& low molecular weight heparin - on the clinical outcome -3 and 6 months after stenting \& also infarct size using troponin level during hospital stay .
Clinical outcome - 3 and 6 months - after stenting which includes re-infarction, repeat percutaneous coronary intervention, coronary artery bypass grafting , Congestive heart failure, cardiac death \& cerebrovascular accidents.
Read the detailed description
Myocardial infarct¬¬¬ion is myocardial necrosis associated with impaired blood perfusion . Until now primary percutaneous coronary intervention (PPCI) is the standard modality of myocardial reperfusion However, there are a considerable number of patients whom still had acute reduction in myocardial blood perfusion after stent implantation even with patent epicardial artery which was defined as "no-reflow" That was explained by the affection of the micro-vasculature. With manipulation of culprit coronary artery lesion, distal embolization can occur, causing micro-vascular embolization \& spasm which will significantly affect myocardial perfusion even with patent epicardial coronary artery Multiple methods were tried to decrease the chances of "no reflow phenomenon". Distal protection devices were used, but unfortunately with no promising results Routine thrombectomy is still controversial.
Deferred stenting, there is still controversy about the use of this strategy. At some studies, immediate stenting in thrombotic context was associated with no-reflow \&distal embolization So ideas about deferred stenting started to glow when Isaac et al tried stenting deferral, after restoring culprit coronary artery patency using minimalist immediate mechanical intervention known as "MIMI - minimalist immediate mechanical intervention -" . That gave green light for further studies to explore benefits and risks of deferred stenting.
However , the strategy is still controversial , as some studies support the use of deferred stenting strategy and found it associated with better endpoints as, reduced no reflow , better myocardial perfusion and salvage lower major adverse cardiovascular events (MACE) , better left ventricular function
However there were other studies which showed no beneficial effect of deferred stenting, but even affect badly the micro-vascular obstruction. Reasons for these conflicting results included:
- Category of patients included where deferred stenting versus immediate stenting to prevent no- or slow-reflow in acute ST-segment elevation myocardial infarction (DEFER-STEMI) enrolled patients at high risk of slow flow based on clinical angiographic features, whereas DANAMI-3 DEFER was all-corner primary PCI study. A deferral strategy should only be applied after careful angiographic selection.
- DEFER-STEMI was angiographic and MRI end-point study whereas DANAMI 3-DEFER looked at clinical outcomes.
- DANAMI 3-DEFER was a larger multi-center randomized study in contrast to DEFER-STEMI.
- The use of GPIIbIIIa inhibitors in Deferred versus conventional stent implantation in patients with ST-segment elevation myocardial infarction (DANAMI 3-DEFER) was significantly lower compared to DEFERED-STEMI.
- There was high crossover to immediate stenting in the defer arm of DANAMI trial which further weakened the results.
- Conditions
- STEMI
- Being tested
- PPCI in heavy thrombus burden STEMI patients
- Keywords
- STEMI patients, Heavy thrombus burden, Deferred stenting, Clinical follow up
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPCI in heavy thrombus burden STEMI patientsDevice
minimally invasive procedures used to open clogged coronary arteries
| Study group | Role | What they receive |
|---|---|---|
| immediate stenting in heavy thrombus STEMI burden patients | Active comparator | This group - heavy thrombus burden STEMI patients with thrombolysis in myocardial infarction ( TIMI ) 2-3 flow - will receive loading dose of GPIIbIIIa inhibitor intracoronary followed by immediate stenting . Receives: Device: PPCI in heavy thrombus burden STEMI patients |
| Deferred stenting in heavy thrombus burden STEMI patients . | Active comparator | This group - heavy thrombus burden STEMI patients with TIMI 2-3 flow - will receive loading dose of GPIIbIIIa inhibitor intracoronary followed by GPIIbIIIa inhibitor infusion and LMWH administration for 48 -72 hours followed by stenting . Receives: Device: PPCI in heavy thrombus burden STEMI patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who develops major adverse cardiovascular events 3 months post PPCI .
Major adverse cardiovascular events include re-infarction, repeat PCI, CABG, Congestive heart failure, cardiac death \& CVS accidents.
Measured: 3 months post PPCI
Number of patients who develops major adverse cardiovascular events 6 months post PPCI .
Major adverse cardiovascular events include re-infarction, repeat PCI, CABG, Congestive heart failure, cardiac death \& CVS accidents.
Measured: 6 months post PPCI
Secondary outcomes (3)
Number of patients who develop major bleeding
major bleeding defined by bleeding in critical area , fatal bleeding , loos in hemoglobin more than 5 gm/dl .
Measured: Within hospital admission
number of patients who develop contrast induced nephropathy
impaired renal function tests including creatinine and urea after contrast use .
Measured: Within hospital admission
Number of patients who develop allergy to tirofiban
developing rash , angioedema , dyspnea as a reaction to tirofiban
Measured: Within hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andro thabet fawzy, Assiut University
- Investigators
- Doaa A. Fouad, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793671
- Sponsor's protocol ID
- Deferred stenting in STEMI
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaffe R, Charron T, Puley G, Dick A, Strauss BH. Microvascular obstruction and the no-reflow phenomenon after percutaneous coronary intervention. Circulation. 2008 Jun 17;117(24):3152-6. doi: 10.1161/CIRCULATIONAHA.107.742312. No abstract available.
PubMed 18559715Stone GW, Webb J, Cox DA, Brodie BR, Qureshi M, Kalynych A, Turco M, Schultheiss HP, Dulas D, Rutherford BD, Antoniucci D, Krucoff MW, Gibbons RJ, Jones D, Lansky AJ, Mehran R; Enhanced Myocardial Efficacy and Recovery by Aspiration of Liberated Debris (EMERALD) Investigators. Distal microcirculatory protection during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: a randomized controlled trial. JAMA. 2005 Mar 2;293(9):1063-72. doi: 10.1001/jama.293.9.1063.
PubMed 15741528Kelbaek H, Terkelsen CJ, Helqvist S, Lassen JF, Clemmensen P, Klovgaard L, Kaltoft A, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Thuesen L. Randomized comparison of distal protection versus conventional treatment in primary percutaneous coronary intervention: the drug elution and distal protection in ST-elevation myocardial infarction (DEDICATION) trial. J Am Coll Cardiol. 2008 Mar 4;51(9):899-905. doi: 10.1016/j.jacc.2007.10.047.
PubMed 18308157Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008 Jun 7;371(9628):1915-20. doi: 10.1016/S0140-6736(08)60833-8.
PubMed 18539223Kaltoft A, Bottcher M, Nielsen SS, Hansen HH, Terkelsen C, Maeng M, Kristensen J, Thuesen L, Krusell LR, Kristensen SD, Andersen HR, Lassen JF, Rasmussen K, Rehling M, Nielsen TT, Botker HE. Routine thrombectomy in percutaneous coronary intervention for acute ST-segment-elevation myocardial infarction: a randomized, controlled trial. Circulation. 2006 Jul 4;114(1):40-7. doi: 10.1161/CIRCULATIONAHA.105.595660. Epub 2006 Jun 26.
PubMed 16801464Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30.
PubMed 17692740Lim SY. No-Reflow Phoenomenon by Intracoronary Thrombus in Acute Myocardial Infarction. Chonnam Med J. 2016 Jan;52(1):38-44. doi: 10.4068/cmj.2016.52.1.38. Epub 2016 Jan 19.
PubMed 26865998Alidoosti M, Lotfi R, Lotfi-Tokaldany M, Nematipour E, Salarifar M, Poorhosseini H, Jalali A. Correlates of the "No-Reflow" or "Slow-Flow" Phenomenon in Patients Undergoing Primary Percutaneous Coronary Intervention. J Tehran Heart Cent. 2018 Jul;13(3):108-114.
PubMed 30745923Henriques JP, Zijlstra F, Ottervanger JP, de Boer MJ, van 't Hof AW, Hoorntje JC, Suryapranata H. Incidence and clinical significance of distal embolization during primary angioplasty for acute myocardial infarction. Eur Heart J. 2002 Jul;23(14):1112-7. doi: 10.1053/euhj.2001.3035.
PubMed 12090749Isaaz K, Robin C, Cerisier A, Lamaud M, Richard L, Da Costa A, Sabry MH, Gerenton C, Blanc JL. A new approach of primary angioplasty for ST-elevation acute myocardial infarction based on minimalist immediate mechanical intervention. Coron Artery Dis. 2006 May;17(3):261-9. doi: 10.1097/00019501-200605000-00010.
PubMed 16728877Ke D, Zhong W, Fan L, Chen L. Delayed versus immediate stenting for the treatment of ST-elevation acute myocardial infarction with a high thrombus burden. Coron Artery Dis. 2012 Nov;23(7):497-506. doi: 10.1097/MCA.0b013e328358a5ad.
PubMed 22968214Carrick D, Oldroyd KG, McEntegart M, Haig C, Petrie MC, Eteiba H, Hood S, Owens C, Watkins S, Layland J, Lindsay M, Peat E, Rae A, Behan M, Sood A, Hillis WS, Mordi I, Mahrous A, Ahmed N, Wilson R, Lasalle L, Genereux P, Ford I, Berry C. A randomized trial of deferred stenting versus immediate stenting to prevent no- or slow-reflow in acute ST-segment elevation myocardial infarction (DEFER-STEMI). J Am Coll Cardiol. 2014 May 27;63(20):2088-2098. doi: 10.1016/j.jacc.2014.02.530. Epub 2014 Feb 27.
PubMed 24583294Pascal J, Veugeois A, Slama M, Rahal S, Belle L, Caussin C, Amabile N. Delayed Stenting for ST-Elevation Acute Myocardial Infarction in Daily Practice: A Single-Centre Experience. Can J Cardiol. 2016 Aug;32(8):988-95. doi: 10.1016/j.cjca.2015.09.015. Epub 2015 Sep 26.
PubMed 26838663Kelbaek H, Hofsten DE, Kober L, Helqvist S, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, De Backer O, Bang LE, Kofoed KF, Lonborg J, Ahtarovski K, Vejlstrup N, Botker HE, Terkelsen CJ, Christiansen EH, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Jensen LO, Clemmensen P, Grande P, Madsen JK, Torp-Pedersen C, Engstrom T. Deferred versus conventional stent implantation in patients with ST-segment elevation myocardial infarction (DANAMI 3-DEFER): an open-label, randomised controlled trial. Lancet. 2016 May 28;387(10034):2199-206. doi: 10.1016/S0140-6736(16)30072-1. Epub 2016 Apr 3.
PubMed 27053444Belle L, Motreff P, Mangin L, Range G, Marcaggi X, Marie A, Ferrier N, Dubreuil O, Zemour G, Souteyrand G, Caussin C, Amabile N, Isaaz K, Dauphin R, Koning R, Robin C, Faurie B, Bonello L, Champin S, Delhaye C, Cuilleret F, Mewton N, Genty C, Viallon M, Bosson JL, Croisille P; MIMI Investigators*. Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study. Circ Cardiovasc Interv. 2016 Mar;9(3):e003388. doi: 10.1161/CIRCINTERVENTIONS.115.003388.
PubMed 26957418
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Clinical and Major Cardiovascular Adverse Events of Deferred Versus Immediate Stenting in High Thrombus Burden STEMI Patients
- ClinicalTrials.gov ID
- NCT05793671
- Acronym / sponsor ID
- Deferred stenting in STEMI
- Conditions
- STEMI
- Keywords
- STEMI patients, Heavy thrombus burden, Deferred stenting, Clinical follow up
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 31 Mar 2023 (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.
To compare the effect of immediate stenting versus deferred stenting - with use of glycoproteinIIbIIIa inhibitor \& low molecular weight heparin - on the clinical outcome -3 and 6 months after stenting \& also infarct size using troponin level during hospital stay .
Clinical outcome - 3 and 6 months - after stenting which includes re-infarction, repeat percutaneous coronary intervention, coronary artery bypass grafting , Congestive heart failure, cardiac death \& cerebrovascular accidents.
Detailed description
Myocardial infarct¬¬¬ion is myocardial necrosis associated with impaired blood perfusion . Until now primary percutaneous coronary intervention (PPCI) is the standard modality of myocardial reperfusion However, there are a considerable number of patients whom still had acute reduction in myocardial blood perfusion after stent implantation even with patent epicardial artery which was defined as "no-reflow" That was explained by the affection of the micro-vasculature. With manipulation of culprit coronary artery lesion, distal embolization can occur, causing micro-vascular embolization \& spasm which will significantly affect myocardial perfusion even with patent epicardial coronary artery Multiple methods were tried to decrease the chances of "no reflow phenomenon". Distal protection devices were used, but unfortunately with no promising results Routine thrombectomy is still controversial.
Deferred stenting, there is still controversy about the use of this strategy. At some studies, immediate stenting in thrombotic context was associated with no-reflow \&distal embolization So ideas about deferred stenting started to glow when Isaac et al tried stenting deferral, after restoring culprit coronary artery patency using minimalist immediate mechanical intervention known as "MIMI - minimalist immediate mechanical intervention -" . That gave green light for further studies to explore benefits and risks of deferred stenting.
However , the strategy is still controversial , as some studies support the use of deferred stenting strategy and found it associated with better endpoints as, reduced no reflow , better myocardial perfusion and salvage lower major adverse cardiovascular events (MACE) , better left ventricular function
However there were other studies which showed no beneficial effect of deferred stenting, but even affect badly the micro-vascular obstruction. Reasons for these conflicting results included:
- Category of patients included where deferred stenting versus immediate stenting to prevent no- or slow-reflow in acute ST-segment elevation myocardial infarction (DEFER-STEMI) enrolled patients at high risk of slow flow based on clinical angiographic features, whereas DANAMI-3 DEFER was all-corner primary PCI study. A deferral strategy should only be applied after careful angiographic selection.
- DEFER-STEMI was angiographic and MRI end-point study whereas DANAMI 3-DEFER looked at clinical outcomes.
- DANAMI 3-DEFER was a larger multi-center randomized study in contrast to DEFER-STEMI.
- The use of GPIIbIIIa inhibitors in Deferred versus conventional stent implantation in patients with ST-segment elevation myocardial infarction (DANAMI 3-DEFER) was significantly lower compared to DEFERED-STEMI.
- There was high crossover to immediate stenting in the defer arm of DANAMI trial which further weakened the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate stenting in heavy thrombus STEMI burden patients | Active comparator | Device: PPCI in heavy thrombus burden STEMI patientsThis group - heavy thrombus burden STEMI patients with thrombolysis in myocardial infarction ( TIMI ) 2-3 flow - will receive loading dose of GPIIbIIIa inhibitor intracoronary followed by immediate stenting . |
| Deferred stenting in heavy thrombus burden STEMI patients . | Active comparator | Device: PPCI in heavy thrombus burden STEMI patientsThis group - heavy thrombus burden STEMI patients with TIMI 2-3 flow - will receive loading dose of GPIIbIIIa inhibitor intracoronary followed by GPIIbIIIa inhibitor infusion and LMWH administration for 48 -72 hours followed by stenting . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Primary percutaneous coronary intervention (PPCI) patients with culprit vessels shows heavy thrombus burden lesions.
- Culprit vessels with TIMI 2-3 either from the beginning or after MIMI (Minimalist immediate mechanical intervention).
Key exclusion criteria (3 listed)
- PPCI patients with low thrombus burden lesions.
- PPCI patient with heavy thrombus burden lesions but with culprit vessels TIMI score 0-1, didn't improve after MIMI.
- patients killip II /III /IV
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 |
|---|---|---|
| PPCI in heavy thrombus burden STEMI patientsminimally invasive procedures used to open clogged coronary arteries | Device | Deferred stenting in heavy thrombus burden STEMI patients ., immediate stenting in heavy thrombus STEMI burden patients |
Primary outcome
Number of patients who develops major adverse cardiovascular events 3 months post PPCI .
Time frame: 3 months post PPCI
Major adverse cardiovascular events include re-infarction, repeat PCI, CABG, Congestive heart failure, cardiac death \& CVS accidents.
Number of patients who develops major adverse cardiovascular events 6 months post PPCI .
Time frame: 6 months post PPCI
Major adverse cardiovascular events include re-infarction, repeat PCI, CABG, Congestive heart failure, cardiac death \& CVS accidents.
3 secondary outcomes
Number of patients who develop major bleeding
Time frame: Within hospital admission
number of patients who develop contrast induced nephropathy
Time frame: Within hospital admission
Number of patients who develop allergy to tirofiban
Time frame: Within hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 18559715Jaffe R, Charron T, Puley G, Dick A, Strauss BH. Microvascular obstruction and the no-reflow phenomenon after percutaneous coronary intervention. Circulation. 2008 Jun 17;117(24):3152-6. doi: 10.1161/CIRCULATIONAHA.107.742312. No abstract available.
- Background: PubMed 15741528Stone GW, Webb J, Cox DA, Brodie BR, Qureshi M, Kalynych A, Turco M, Schultheiss HP, Dulas D, Rutherford BD, Antoniucci D, Krucoff MW, Gibbons RJ, Jones D, Lansky AJ, Mehran R; Enhanced Myocardial Efficacy and Recovery by Aspiration of Liberated Debris (EMERALD) Investigators. Distal microcirculatory protection during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: a randomized controlled trial. JAMA. 2005 Mar 2;293(9):1063-72. doi: 10.1001/jama.293.9.1063.
- Background: PubMed 18308157Kelbaek H, Terkelsen CJ, Helqvist S, Lassen JF, Clemmensen P, Klovgaard L, Kaltoft A, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Thuesen L. Randomized comparison of distal protection versus conventional treatment in primary percutaneous coronary intervention: the drug elution and distal protection in ST-elevation myocardial infarction (DEDICATION) trial. J Am Coll Cardiol. 2008 Mar 4;51(9):899-905. doi: 10.1016/j.jacc.2007.10.047.
- Background: PubMed 18539223Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008 Jun 7;371(9628):1915-20. doi: 10.1016/S0140-6736(08)60833-8.
- Background: PubMed 16801464Kaltoft A, Bottcher M, Nielsen SS, Hansen HH, Terkelsen C, Maeng M, Kristensen J, Thuesen L, Krusell LR, Kristensen SD, Andersen HR, Lassen JF, Rasmussen K, Rehling M, Nielsen TT, Botker HE. Routine thrombectomy in percutaneous coronary intervention for acute ST-segment-elevation myocardial infarction: a randomized, controlled trial. Circulation. 2006 Jul 4;114(1):40-7. doi: 10.1161/CIRCULATIONAHA.105.595660. Epub 2006 Jun 26.
- Background: PubMed 17692740Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30.
- Background: PubMed 26865998Lim SY. No-Reflow Phoenomenon by Intracoronary Thrombus in Acute Myocardial Infarction. Chonnam Med J. 2016 Jan;52(1):38-44. doi: 10.4068/cmj.2016.52.1.38. Epub 2016 Jan 19.
- Background: PubMed 30745923Alidoosti M, Lotfi R, Lotfi-Tokaldany M, Nematipour E, Salarifar M, Poorhosseini H, Jalali A. Correlates of the "No-Reflow" or "Slow-Flow" Phenomenon in Patients Undergoing Primary Percutaneous Coronary Intervention. J Tehran Heart Cent. 2018 Jul;13(3):108-114.
- Background: PubMed 12090749Henriques JP, Zijlstra F, Ottervanger JP, de Boer MJ, van 't Hof AW, Hoorntje JC, Suryapranata H. Incidence and clinical significance of distal embolization during primary angioplasty for acute myocardial infarction. Eur Heart J. 2002 Jul;23(14):1112-7. doi: 10.1053/euhj.2001.3035.
- Background: PubMed 16728877Isaaz K, Robin C, Cerisier A, Lamaud M, Richard L, Da Costa A, Sabry MH, Gerenton C, Blanc JL. A new approach of primary angioplasty for ST-elevation acute myocardial infarction based on minimalist immediate mechanical intervention. Coron Artery Dis. 2006 May;17(3):261-9. doi: 10.1097/00019501-200605000-00010.
- Background: PubMed 22968214Ke D, Zhong W, Fan L, Chen L. Delayed versus immediate stenting for the treatment of ST-elevation acute myocardial infarction with a high thrombus burden. Coron Artery Dis. 2012 Nov;23(7):497-506. doi: 10.1097/MCA.0b013e328358a5ad.
- Background: PubMed 24583294Carrick D, Oldroyd KG, McEntegart M, Haig C, Petrie MC, Eteiba H, Hood S, Owens C, Watkins S, Layland J, Lindsay M, Peat E, Rae A, Behan M, Sood A, Hillis WS, Mordi I, Mahrous A, Ahmed N, Wilson R, Lasalle L, Genereux P, Ford I, Berry C. A randomized trial of deferred stenting versus immediate stenting to prevent no- or slow-reflow in acute ST-segment elevation myocardial infarction (DEFER-STEMI). J Am Coll Cardiol. 2014 May 27;63(20):2088-2098. doi: 10.1016/j.jacc.2014.02.530. Epub 2014 Feb 27.
- Individual participant dataSharing planned: No
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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.
Doaa A. Fouad, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing PPCI in heavy thrombus burden STEMI patients in people with STEMI, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Andro Thabet Fawzy, Bachelor (+201200012699, Thabetandro70@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who develops major adverse cardiovascular events 3 months post PPCI . (time frame: 3 months post PPCI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05793671, which also lists 15 linked publications.
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 31 Mar 2023.