Left Ventricle RemodelingNCT03888781
Long Term Follow Up and Outcome of Left Ventricular Remodeling in ST Segment Myocardial Infarction Patients After pPCI
An observational study of Left Ventricle Remodeling, run by Assiut University.
Trial summary
To detect long-term effects of left ventricular remodeling in STEMI patients undergoing PPCI. And to evaluate outcome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Left Ventricle Remodeling
- What is being tested?
- Echocardiography
- Type of treatment
- Medical device
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to Jun 2020
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: * It is a cross sectional observational study conducted in Asyut University Cardiac Hospital for STEMI patients to whom PPCI were done. The study includes 127 acute STEMI patients to whom PPCI were done more than 2 years ago. * History and clinical examination, ECG diagnosis and location of STEMI, Angiographic study, 2D Echocardiographic examination were done to them.
Who may be able to join
- All patients were treated successfully by primary PCI more than 2 years ago within 12 hours of onset of chest pain or up to 24 hour of onset of chest pain if there was ongoing ischemia at Assiut University Cardiac Hospital Cath. lab.
Who cannot join
- Patients with clinical manifestations of acute heart failure or cardiogenic shock at presentation.
- Significant Mitral regurgitation or valve disease.
- Patients with permanent pacemaker insertion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Long Term Follow Up and Outcome of Left Ventricular Remodeling in ST Segment Myocardial Infarction Patients After Primary Percutaneous Coronary Intervention
- To detect long-term effects of left ventricular remodeling in STEMI patients undergoing PPCI.
- And to evaluate outcome.
Read the detailed description
Acute myocardial infarction (AMI) with its accompanying adverse sequelae remains one of the most common causes of morbidity and mortality in the world .
Reperfusion therapy is by far the most important therapy for the treatment of acute MI. Reperfusion of the ischemic myocardium reduces the infarct size and improves left ventricular function, both of which contribute to an improved clinical outcome in patients with acute MI .
Using primary PCI has reduced the mortality of patients with acute MI . However, the increased survival rate resulted in the increased incidence of cardio vascular events mainly due to LV remodeling and congestive heart failure .
Post-infarct ventricular remodeling develops in about 30% of patients with a history of myocardial infarction. Ventricular remodeling is a predictor of heart failure and for this reason it assumes a negative prognostic value .
Left ventricular remodeling after ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention is a major determinant for the short-term and long-term clinical outcomes . Adverse left ventricular remodeling refers to alterations in ventricular architecture involving both the infarcted and non-infarcted zones leading to progressive increase in systolic and diastolic left ventricular volumes.
Left ventricular remodeling following a ST-segment elevated myocardial infarction (STEMI) is an adaptive response to maintain the cardiac output despite myocardial tissue loss. Limited studies have evaluated long term ventricular function after STEMI.
Left Ventricular remodeling, both positive and negative, is an ongoing process and continues at least up to 2 years after STEMI, involving the infarct zone and remote zones. Long-term left ventricular ejection fraction (LVEF) deterioration is characterized by an increase in end-systolic volume and less wall thickening in the remote zones. Patients with long-term LVEF improvement exhibit an increase in left ventricular wall thickening both in the transmural infarct and remote zones. For elucidation of long term effects of left ventricular remodeling, the current study is conducted.
- Conditions
- Left Ventricle Remodeling
- Being tested
- Echocardiography
- Medical subject headings
- Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDevice
An echocardiogram (also called an echo) is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.
| Study group | Role | What they receive |
|---|---|---|
| With Left Ventricular Remodeling | By Echocardiography Receives: Device: Echocardiography | |
| Without Left Ventricular Remodeling | By Echocardiography Receives: Device: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term effect of primary percutaneous coronary intervention on left ventricular remodeling, as measured by change in left ventricular ejection fraction (LVEF) at one year
Left ventricular remodeling follow up to 127 of acute STEMI patients to whom PPCI were done by 2D Echocardiography measurement to left ventricular ejection fraction change by modified simpthon method
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 May 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Left Ventricle RemodelingStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Amir Adly Eskander, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888781
- Sponsor's protocol ID
- Long Term LV Remodeling
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):e6-e245. doi: 10.1161/CIR.0b013e31828124ad. Epub 2012 Dec 12. No abstract available.
PubMed 23239837Rossini R, Senni M, Musumeci G, Ferrazzi P, Gavazzi A. Prevention of left ventricular remodelling after acute myocardial infarction: an update. Recent Pat Cardiovasc Drug Discov. 2010 Nov;5(3):196-207. doi: 10.2174/157489010793351999.
PubMed 20874671Lunde K, Solheim S, Aakhus S, Arnesen H, Abdelnoor M, Egeland T, Endresen K, Ilebekk A, Mangschau A, Fjeld JG, Smith HJ, Taraldsrud E, Grogaard HK, Bjornerheim R, Brekke M, Muller C, Hopp E, Ragnarsson A, Brinchmann JE, Forfang K. Intracoronary injection of mononuclear bone marrow cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1199-209. doi: 10.1056/NEJMoa055706.
PubMed 16990383Flachskampf FA, Schmid M, Rost C, Achenbach S, DeMaria AN, Daniel WG. Cardiac imaging after myocardial infarction. Eur Heart J. 2011 Feb;32(3):272-83. doi: 10.1093/eurheartj/ehq446. Epub 2010 Dec 16.
PubMed 21163851St John Sutton M, Pfeffer MA, Moye L, Plappert T, Rouleau JL, Lamas G, Rouleau J, Parker JO, Arnold MO, Sussex B, Braunwald E. Cardiovascular death and left ventricular remodeling two years after myocardial infarction: baseline predictors and impact of long-term use of captopril: information from the Survival and Ventricular Enlargement (SAVE) trial. Circulation. 1997 Nov 18;96(10):3294-9. doi: 10.1161/01.cir.96.10.3294.
PubMed 9396419Opie LH, Commerford PJ, Gersh BJ, Pfeffer MA. Controversies in ventricular remodelling. Lancet. 2006 Jan 28;367(9507):356-67. doi: 10.1016/S0140-6736(06)68074-4.
PubMed 16443044Cohn JN, Ferrari R, Sharpe N. Cardiac remodeling--concepts and clinical implications: a consensus paper from an international forum on cardiac remodeling. Behalf of an International Forum on Cardiac Remodeling. J Am Coll Cardiol. 2000 Mar 1;35(3):569-82. doi: 10.1016/s0735-1097(99)00630-0.
PubMed 10716457
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow Up and Outcome of Left Ventricular Remodeling in ST Segment Myocardial Infarction Patients After Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03888781
- Acronym / sponsor ID
- Long Term LV Remodeling
- Conditions
- Left Ventricle Remodeling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 25 Mar 2019 (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 detect long-term effects of left ventricular remodeling in STEMI patients undergoing PPCI.
- And to evaluate outcome.
Detailed description
Acute myocardial infarction (AMI) with its accompanying adverse sequelae remains one of the most common causes of morbidity and mortality in the world .
Reperfusion therapy is by far the most important therapy for the treatment of acute MI. Reperfusion of the ischemic myocardium reduces the infarct size and improves left ventricular function, both of which contribute to an improved clinical outcome in patients with acute MI .
Using primary PCI has reduced the mortality of patients with acute MI . However, the increased survival rate resulted in the increased incidence of cardio vascular events mainly due to LV remodeling and congestive heart failure .
Post-infarct ventricular remodeling develops in about 30% of patients with a history of myocardial infarction. Ventricular remodeling is a predictor of heart failure and for this reason it assumes a negative prognostic value .
Left ventricular remodeling after ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention is a major determinant for the short-term and long-term clinical outcomes . Adverse left ventricular remodeling refers to alterations in ventricular architecture involving both the infarcted and non-infarcted zones leading to progressive increase in systolic and diastolic left ventricular volumes.
Left ventricular remodeling following a ST-segment elevated myocardial infarction (STEMI) is an adaptive response to maintain the cardiac output despite myocardial tissue loss. Limited studies have evaluated long term ventricular function after STEMI.
Left Ventricular remodeling, both positive and negative, is an ongoing process and continues at least up to 2 years after STEMI, involving the infarct zone and remote zones. Long-term left ventricular ejection fraction (LVEF) deterioration is characterized by an increase in end-systolic volume and less wall thickening in the remote zones. Patients with long-term LVEF improvement exhibit an increase in left ventricular wall thickening both in the transmural infarct and remote zones. For elucidation of long term effects of left ventricular remodeling, the current study is conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Left Ventricular Remodeling | – | Device: EchocardiographyBy Echocardiography |
| Without Left Ventricular Remodeling | – | Device: EchocardiographyBy Echocardiography |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * It is a cross sectional observational study conducted in Asyut University Cardiac Hospital for STEMI patients to whom PPCI were done. The study includes 127 acute STEMI patients to whom PPCI were done more than 2 years ago. * History and clinical examination, ECG diagnosis and location of STEMI, Angiographic study, 2D Echocardiographic examination were done to them.
Key inclusion criteria (1 listed)
- All patients were treated successfully by primary PCI more than 2 years ago within 12 hours of onset of chest pain or up to 24 hour of onset of chest pain if there was ongoing ischemia at Assiut University Cardiac Hospital Cath. lab.
Key exclusion criteria (3 listed)
- Patients with clinical manifestations of acute heart failure or cardiogenic shock at presentation.
- Significant Mitral regurgitation or valve disease.
- Patients with permanent pacemaker insertion.
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 |
|---|---|---|
| EchocardiographyAn echocardiogram (also called an echo) is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen. | Device | With Left Ventricular Remodeling, Without Left Ventricular Remodeling |
Primary outcome
Long term effect of primary percutaneous coronary intervention on left ventricular remodeling, as measured by change in left ventricular ejection fraction (LVEF) at one year
Time frame: one year
Left ventricular remodeling follow up to 127 of acute STEMI patients to whom PPCI were done by 2D Echocardiography measurement to left ventricular ejection fraction change by modified simpthon method
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Background: PubMed 23239837Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):e6-e245. doi: 10.1161/CIR.0b013e31828124ad. Epub 2012 Dec 12. No abstract available.
- Background: PubMed 20874671Rossini R, Senni M, Musumeci G, Ferrazzi P, Gavazzi A. Prevention of left ventricular remodelling after acute myocardial infarction: an update. Recent Pat Cardiovasc Drug Discov. 2010 Nov;5(3):196-207. doi: 10.2174/157489010793351999.
- Background: PubMed 16990383Lunde K, Solheim S, Aakhus S, Arnesen H, Abdelnoor M, Egeland T, Endresen K, Ilebekk A, Mangschau A, Fjeld JG, Smith HJ, Taraldsrud E, Grogaard HK, Bjornerheim R, Brekke M, Muller C, Hopp E, Ragnarsson A, Brinchmann JE, Forfang K. Intracoronary injection of mononuclear bone marrow cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1199-209. doi: 10.1056/NEJMoa055706.
- Background: PubMed 21163851Flachskampf FA, Schmid M, Rost C, Achenbach S, DeMaria AN, Daniel WG. Cardiac imaging after myocardial infarction. Eur Heart J. 2011 Feb;32(3):272-83. doi: 10.1093/eurheartj/ehq446. Epub 2010 Dec 16.
- Background: PubMed 9396419St John Sutton M, Pfeffer MA, Moye L, Plappert T, Rouleau JL, Lamas G, Rouleau J, Parker JO, Arnold MO, Sussex B, Braunwald E. Cardiovascular death and left ventricular remodeling two years after myocardial infarction: baseline predictors and impact of long-term use of captopril: information from the Survival and Ventricular Enlargement (SAVE) trial. Circulation. 1997 Nov 18;96(10):3294-9. doi: 10.1161/01.cir.96.10.3294.
- Background: PubMed 16443044Opie LH, Commerford PJ, Gersh BJ, Pfeffer MA. Controversies in ventricular remodelling. Lancet. 2006 Jan 28;367(9507):356-67. doi: 10.1016/S0140-6736(06)68074-4.
- Background: PubMed 10716457Cohn JN, Ferrari R, Sharpe N. Cardiac remodeling--concepts and clinical implications: a consensus paper from an international forum on cardiac remodeling. Behalf of an International Forum on Cardiac Remodeling. J Am Coll Cardiol. 2000 Mar 1;35(3):569-82. doi: 10.1016/s0735-1097(99)00630-0.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricle Remodeling, 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 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: status not confirmed, as of the sponsor's last update on 25 Mar 2019. 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 Yara Amir, Resident Dr (+201064010505, yaraamir2311@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term effect of primary percutaneous coronary intervention on left ventricular remodeling, as measured by change in left ventricular ejection fraction (LVEF) at one year (time frame: one year). 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 NCT03888781, which also lists 7 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 25 Mar 2019.