Insulin Resistance and PCINCT04651842
Impact of Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
An observational study of Insulin Resistance and PCI, run by Assiut University at 1 site in Egypt.
Trial summary
Full myocardial reperfusion with restoration of coronary microcirculatory function (CMF) is a therapeutic goal in ST-segment elevation myocardial infarction (STEMI).1 Despite the success of primary percutaneous coronary intervention (pPCI), it is not achieved in 30% to 50% of patients.2,3 Insulin resistance (IR) as a… Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Insulin Resistance and PCI
- What is being tested?
- PCI
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to 1 May 2019
- Phase
- Observational
- 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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 240 non-diabetic patients with acute STEMI of both sexes and different ages selected from cardiology department in Assiut University Hospital who underwent primary percutaneous coronary intervention (PCI) between first of May 2018 and first of May 2019.
Who may be able to join
- This cross-sectional comparative study included 240 non-diabetic patients with acute STEMI of both sexes and different ages selected from cardiology department in Assiut University Hospital who underwent primary percutaneous coronary intervention (PCI) between first of May 2018 and first of May 2019.
Who cannot join
- Patients were excluded from this study if they had diabetes mellitus; renal insufficiency (creatinine >2 mg/dl); advanced hepatic dysfunction; taken anti-oxidant supplement/therapy within the past 4 weeks before enrollment; pregnant; were alcoholic; had allergy to radiographic contrast; uncooperative patient or patient refusal; also if they had malignancy; chronic heart failure or cardiomyopathy; prior myocardial infarction and diseases requiring steroid therapy
Trial locations and contacts
1 site in 1 country.
About this study
Full myocardial reperfusion with restoration of coronary microcirculatory function (CMF) is a therapeutic goal in ST-segment elevation myocardial infarction (STEMI).1 Despite the success of primary percutaneous coronary intervention (pPCI), it is not achieved in 30% to 50% of patients.2,3 Insulin resistance (IR) as a part of metabolic syndrome is an important risk factor for the development of cardiac and vascular impairments and carries ominous prognosis in the setting of acute myocardial infarction.4 As a part of metabolic syndrome, IR is associated with myocardial and microvascular injury after STEMI in clinical studies. As phenomenon per se, independent of other components of metabolic syndrome, IR was related to ischemic myocardial injury after elective PCI.5
Recently, IR in the early phase of acute coronary syndrome in non-diabetic patients, assessed by the homeostatic model assessment (HOMA) index, was established as an independent predictor of in-hospital mortality. This "acute" IR is a part of the acute glycometabolic response to stress, can be transient and can occur even in patients without chronic glycometabolic derangements.6
Read more
Acute IR comprises acute hyperglycemia and/or acute hyperinsulinemia; Hyperglycemia has the prognostic relevance of hyperinsulinemia in STEMI patients and its relationship with coronary flow are less well evaluated.it also acknowledged direct acute negative cardiovascular effects as it is contributing to incomplete myocardial reperfusion and CMF impairment. The prognostic relevance of hyperinsulinemia in STEMI patients and its relationship with coronary flow are less well evaluated and acknowledged.7,8 Myocardial blush was first defined by Arnoud van't Hof etal . It is a qualitative visual assessment of the amount of contrast medium filling a territory supplied by a pericardial coronary artery.9 Myocardial blush grade is a valuable tool for assessing coronary microvasculature and myocardial perfusion in patients undergoing coronary angiography and angioplasty.
Reduced myocardial blush grade identifies patients at higher risk who need more aggressive treatment both during the procedure to improve myocardial perfusion and later for secondary prevention.10
We postulate that IR can occur in the early post pPCI period as a dynamic phenomenon even in non-diabetic patients, and be related to the development of microvascular injury. We have defined myocardial blush as a marker of coronary microvascular function, Accordingly, we have evaluated IR in relation to myocardial blush in non-diabetic STEMI patients treated by pPCI. as a primary end-point. The residual ST-segment elevation, post-TFC%; and MACE were secondary end points. The HOMA index is a simple and inexpensive marker of IR primary used in chronic states. It was recently validated against euglycemic hyperinsulinemic clamp in STEMI patients as feasible for assessing IR during myocardial infarction and therefore used in the current study.11
Read the detailed description
Myocardial blush grade is valuable tool for assessing coronary microvasculature and myocardial perfusion in patients undergoing coronary angiography and angioplasty and its reduction identifies patients at high risk. In this study we investigate the association of acute insulin resistance with myocardial blush grade and outcome in non-diabetic patients with ST-segment elevation myocardial infarction (STEMI).
- Conditions
- Insulin Resistance and PCI
- Being tested
- PCI
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIDevice
Also called primary Insulin resistance
Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
| Study group | Role | What they receive |
|---|---|---|
| HOMA IR high | classified based on equal tertile of HOMA IR level into 3 equal groups ( high>6.6) Receives: Device: PCI | |
| HOMA IR intermediate | classified based on equal tertile of HOMA IR level into 3 equal groups ( intermediate 4.6-6.6, ) Receives: Device: PCI | |
| HOMA IR low | classified based on equal tertile of HOMA IR level into 3 equal groups (low ≤ 4.6, ) Receives: Device: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
arrythmia,LVF,Pulmonary edema,Cardiogenic shock, In hospital re-infarction,In hospital stent thrombosis
Measured: May2018 to May 2019
Secondary outcomes (1)
In hospial mortality
Measured: May 2018 to May2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 May 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Insulin Resistance and PCIStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soher Moustafa Kasem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651842
- Sponsor's protocol ID
- Insulin resistance and PCI
- Status last verified
- Nov 2020
- First submitted
- 26 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lerman A, Holmes DR, Herrmann J, Gersh BJ. Microcirculatory dysfunction in ST-elevation myocardial infarction: cause, consequence, or both? Eur Heart J. 2007 Apr;28(7):788-97. doi: 10.1093/eurheartj/ehl501. Epub 2007 Mar 8.
PubMed 17347176Niccoli G, Burzotta F, Galiuto L, Crea F. Myocardial no-reflow in humans. J Am Coll Cardiol. 2009 Jul 21;54(4):281-92. doi: 10.1016/j.jacc.2009.03.054.
PubMed 19608025Arnold SV, Lipska KJ, Li Y, Goyal A, Maddox TM, McGuire DK, Spertus JA, Kosiborod M. The reliability and prognosis of in-hospital diagnosis of metabolic syndrome in the setting of acute myocardial infarction. J Am Coll Cardiol. 2013 Aug 20;62(8):704-8. doi: 10.1016/j.jacc.2013.02.062. Epub 2013 Apr 3.
PubMed 23563136Uetani T, Amano T, Harada K, Kitagawa K, Kunimura A, Shimbo Y, Harada K, Yoshida T, Kato B, Kato M, Marui N, Nanki M, Hotta N, Ishii H, Matsubara T, Murohara T. Impact of insulin resistance on post-procedural myocardial injury and clinical outcomes in patients who underwent elective coronary interventions with drug-eluting stents. JACC Cardiovasc Interv. 2012 Nov;5(11):1159-67. doi: 10.1016/j.jcin.2012.07.008.
PubMed 23174640Sanjuan R, Blasco ML, Huerta R, Palacios L, Carratala A, Nunyez J, Sanchis J. Insulin resistance and short-term mortality in patients with acute myocardial infarction. Int J Cardiol. 2014 Mar 15;172(2):e269-70. doi: 10.1016/j.ijcard.2013.12.207. Epub 2014 Jan 8. No abstract available.
PubMed 24485226Zarich SW, Nesto RW. Implications and treatment of acute hyperglycemia in the setting of acute myocardial infarction. Circulation. 2007 May 8;115(18):e436-9. doi: 10.1161/CIRCULATIONAHA.105.535732. No abstract available.
PubMed 17485582van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation. 1998 Jun 16;97(23):2302-6. doi: 10.1161/01.cir.97.23.2302.
PubMed 9639373Tsvetkov H, Mosseri M. Myocardial blush grade: an interventional method for assessing myocardial perfusion. Isr Med Assoc J. 2008 Jun;10(6):465-7. No abstract available.
PubMed 18669149Moura FA, Carvalho LS, Cintra RM, Martins NV, Figueiredo VN, Quinaglia e Silva JC, Almeida OL, Coelho OR, Sposito AC. Validation of surrogate indexes of insulin sensitivity in acute phase of myocardial infarction based on euglycemic-hyperinsulinemic clamp. Am J Physiol Endocrinol Metab. 2014 Feb 15;306(4):E399-403. doi: 10.1152/ajpendo.00566.2013. Epub 2013 Dec 17.
PubMed 24347056American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.
PubMed 22187469James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.
PubMed 24352797Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, Pasternak RC, Smith SC Jr, Stone NJ; Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. J Am Coll Cardiol. 2004 Aug 4;44(3):720-32. doi: 10.1016/j.jacc.2004.07.001.
PubMed 15358046de Boer MJ, Reiber JH, Suryapranata H, van den Brand MJ, Hoorntje JC, Zijlstra F. Angiographic findings and catheterization laboratory events in patients with primary coronary angioplasty or streptokinase therapy for acute myocardial infarction. Eur Heart J. 1995 Oct;16(10):1347-55. doi: 10.1093/oxfordjournals.eurheartj.a060741.
PubMed 8746902TIMI Study Group. The Thrombolysis in Myocardial Infarction (TIMI) trial. Phase I findings. N Engl J Med. 1985 Apr 4;312(14):932-6. doi: 10.1056/NEJM198504043121437. No abstract available.
PubMed 4038784Gibson CM, Cannon CP, Daley WL, Dodge JT Jr, Alexander B Jr, Marble SJ, McCabe CH, Raymond L, Fortin T, Poole WK, Braunwald E. TIMI frame count: a quantitative method of assessing coronary artery flow. Circulation. 1996 Mar 1;93(5):879-88. doi: 10.1161/01.cir.93.5.879.
PubMed 8598078
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04651842
- Acronym / sponsor ID
- Insulin resistance and PCI
- Conditions
- Insulin Resistance and PCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 3 Dec 2020 (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.
Full myocardial reperfusion with restoration of coronary microcirculatory function (CMF) is a therapeutic goal in ST-segment elevation myocardial infarction (STEMI).1 Despite the success of primary percutaneous coronary intervention (pPCI), it is not achieved in 30% to 50% of patients.2,3 Insulin resistance (IR) as a part of metabolic syndrome is an important risk factor for the development of cardiac and vascular impairments and carries ominous prognosis in the setting of acute myocardial infarction.4 As a part of metabolic syndrome, IR is associated with myocardial and microvascular injury after STEMI in clinical studies. As phenomenon per se, independent of other components of metabolic syndrome, IR was related to ischemic myocardial injury after elective PCI.5
Recently, IR in the early phase of acute coronary syndrome in non-diabetic patients, assessed by the homeostatic model assessment (HOMA) index, was established as an independent predictor of in-hospital mortality. This "acute" IR is a part of the acute glycometabolic response to stress, can be transient and can occur even in patients without chronic glycometabolic derangements.6
Acute IR comprises acute hyperglycemia and/or acute hyperinsulinemia; Hyperglycemia has the prognostic relevance of hyperinsulinemia in STEMI patients and its relationship with coronary flow are less well evaluated.it also acknowledged direct acute negative cardiovascular effects as it is contributing to incomplete myocardial reperfusion and CMF impairment. The prognostic relevance of hyperinsulinemia in STEMI patients and its relationship with coronary flow are less well evaluated and acknowledged.7,8 Myocardial blush was first defined by Arnoud van't Hof etal . It is a qualitative visual assessment of the amount of contrast medium filling a territory supplied by a pericardial coronary artery.9 Myocardial blush grade is a valuable tool for assessing coronary microvasculature and myocardial perfusion in patients undergoing coronary angiography and angioplasty.
Reduced myocardial blush grade identifies patients at higher risk who need more aggressive treatment both during the procedure to improve myocardial perfusion and later for secondary prevention.10
We postulate that IR can occur in the early post pPCI period as a dynamic phenomenon even in non-diabetic patients, and be related to the development of microvascular injury. We have defined myocardial blush as a marker of coronary microvascular function, Accordingly, we have evaluated IR in relation to myocardial blush in non-diabetic STEMI patients treated by pPCI. as a primary end-point. The residual ST-segment elevation, post-TFC%; and MACE were secondary end points. The HOMA index is a simple and inexpensive marker of IR primary used in chronic states. It was recently validated against euglycemic hyperinsulinemic clamp in STEMI patients as feasible for assessing IR during myocardial infarction and therefore used in the current study.11
Detailed description
Myocardial blush grade is valuable tool for assessing coronary microvasculature and myocardial perfusion in patients undergoing coronary angiography and angioplasty and its reduction identifies patients at high risk. In this study we investigate the association of acute insulin resistance with myocardial blush grade and outcome in non-diabetic patients with ST-segment elevation myocardial infarction (STEMI).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HOMA IR high | – | Device: PCIclassified based on equal tertile of HOMA IR level into 3 equal groups ( high>6.6) |
| HOMA IR intermediate | – | Device: PCIclassified based on equal tertile of HOMA IR level into 3 equal groups ( intermediate 4.6-6.6, ) |
| HOMA IR low | – | Device: PCIclassified based on equal tertile of HOMA IR level into 3 equal groups (low ≤ 4.6, ) |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 240 non-diabetic patients with acute STEMI of both sexes and different ages selected from cardiology department in Assiut University Hospital who underwent primary percutaneous coronary intervention (PCI) between first of May 2018 and first of May 2019.
Key inclusion criteria (1 listed)
- This cross-sectional comparative study included 240 non-diabetic patients with acute STEMI of both sexes and different ages selected from cardiology department in Assiut University Hospital who underwent primary percutaneous coronary intervention (PCI) between first of May 2018 and first of May 2019.
Key exclusion criteria (1 listed)
- Patients were excluded from this study if they had diabetes mellitus; renal insufficiency (creatinine >2 mg/dl); advanced hepatic dysfunction; taken anti-oxidant supplement/therapy within the past 4 weeks before enrollment; pregnant; were alcoholic; had allergy to radiographic contrast; uncooperative patient or patient refusal; also if they had malignancy; chronic heart failure or cardiomyopathy; prior myocardial infarction and diseases requiring steroid therapy
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 |
|---|---|---|
| PCIAlso: primary Insulin resistanceAcute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention | Device | HOMA IR high, HOMA IR intermediate, HOMA IR low |
Primary outcome
arrythmia,LVF,Pulmonary edema,Cardiogenic shock, In hospital re-infarction,In hospital stent thrombosis
Time frame: May2018 to May 2019
1 secondary outcome
In hospial mortality
Time frame: May 2018 to May2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Background: PubMed 17347176Lerman A, Holmes DR, Herrmann J, Gersh BJ. Microcirculatory dysfunction in ST-elevation myocardial infarction: cause, consequence, or both? Eur Heart J. 2007 Apr;28(7):788-97. doi: 10.1093/eurheartj/ehl501. Epub 2007 Mar 8.
- Background: PubMed 19608025Niccoli G, Burzotta F, Galiuto L, Crea F. Myocardial no-reflow in humans. J Am Coll Cardiol. 2009 Jul 21;54(4):281-92. doi: 10.1016/j.jacc.2009.03.054.
- Background: PubMed 23563136Arnold SV, Lipska KJ, Li Y, Goyal A, Maddox TM, McGuire DK, Spertus JA, Kosiborod M. The reliability and prognosis of in-hospital diagnosis of metabolic syndrome in the setting of acute myocardial infarction. J Am Coll Cardiol. 2013 Aug 20;62(8):704-8. doi: 10.1016/j.jacc.2013.02.062. Epub 2013 Apr 3.
- Background: PubMed 23174640Uetani T, Amano T, Harada K, Kitagawa K, Kunimura A, Shimbo Y, Harada K, Yoshida T, Kato B, Kato M, Marui N, Nanki M, Hotta N, Ishii H, Matsubara T, Murohara T. Impact of insulin resistance on post-procedural myocardial injury and clinical outcomes in patients who underwent elective coronary interventions with drug-eluting stents. JACC Cardiovasc Interv. 2012 Nov;5(11):1159-67. doi: 10.1016/j.jcin.2012.07.008.
- Background: PubMed 24485226Sanjuan R, Blasco ML, Huerta R, Palacios L, Carratala A, Nunyez J, Sanchis J. Insulin resistance and short-term mortality in patients with acute myocardial infarction. Int J Cardiol. 2014 Mar 15;172(2):e269-70. doi: 10.1016/j.ijcard.2013.12.207. Epub 2014 Jan 8. No abstract available.
- Background: PubMed 17485582Zarich SW, Nesto RW. Implications and treatment of acute hyperglycemia in the setting of acute myocardial infarction. Circulation. 2007 May 8;115(18):e436-9. doi: 10.1161/CIRCULATIONAHA.105.535732. No abstract available.
- Background: PubMed 9639373van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation. 1998 Jun 16;97(23):2302-6. doi: 10.1161/01.cir.97.23.2302.
- Background: PubMed 18669149Tsvetkov H, Mosseri M. Myocardial blush grade: an interventional method for assessing myocardial perfusion. Isr Med Assoc J. 2008 Jun;10(6):465-7. No abstract available.
- Background: PubMed 24347056Moura FA, Carvalho LS, Cintra RM, Martins NV, Figueiredo VN, Quinaglia e Silva JC, Almeida OL, Coelho OR, Sposito AC. Validation of surrogate indexes of insulin sensitivity in acute phase of myocardial infarction based on euglycemic-hyperinsulinemic clamp. Am J Physiol Endocrinol Metab. 2014 Feb 15;306(4):E399-403. doi: 10.1152/ajpendo.00566.2013. Epub 2013 Dec 17.
- Background: PubMed 22187469American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.
- Background: PubMed 24352797James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.
- Background: PubMed 15358046Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, Pasternak RC, Smith SC Jr, Stone NJ; Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. J Am Coll Cardiol. 2004 Aug 4;44(3):720-32. doi: 10.1016/j.jacc.2004.07.001.
Related trials for Insulin Resistance and PCI
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Insulin Resistance and Its Association With no Reflow Phenomenon After Primary PCI in Type II Diabetic STEMI Patients.
STEMI, No-Reflow Phenomenon
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and PCI, run by Assiut University at 1 site 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 1 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: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
arrythmia,LVF,Pulmonary edema,Cardiogenic shock, In hospital re-infarction,In hospital stent thrombosis (time frame: May2018 to May 2019). 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 NCT04651842, which also lists 28 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 3 Dec 2020.