Clinical trial NCT03888781: Long Term Follow Up and Outcome of Left Ventricular Remodeling in ST Segment Myocardial Infarction Patients After pPCI
Official title: Long Term Follow Up and Outcome of Left Ventricular Remodeling in ST Segment Myocardial Infarction Patients After Primary Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Left Ventricle Remodeling
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: * 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients with clinical manifestations of acute heart failure or cardiogenic shock at presentation.
* Significant Mitral regurgitation or valve disease.
* Patients with permanent pacemaker insertion.

Primary outcomes:
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
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Rossini 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.
citation: Lunde 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.
citation: Flachskampf 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.
citation: St 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.
citation: Opie 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.
citation: Cohn 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.