NCT03888781

Brief Summary

  • To detect long-term effects of left ventricular remodeling in STEMI patients undergoing PPCI.
  • And to evaluate outcome.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 8, 2019

Last Update Submit

March 22, 2019

Conditions

Left Ventricle Remodeling

Outcome Measures

Primary Outcomes (1)

  • 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

    one year

Study Arms (2)

With Left Ventricular Remodeling

By Echocardiography

Device: Echocardiography

Without Left Ventricular Remodeling

By Echocardiography

Device: Echocardiography

Interventions

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.

With Left Ventricular RemodelingWithout Left Ventricular Remodeling

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 23239837BACKGROUND

  • 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.

    PMID: 20874671BACKGROUND

  • 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.

    PMID: 16990383BACKGROUND

  • 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.

    PMID: 21163851BACKGROUND

  • 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.

    PMID: 9396419BACKGROUND

  • 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.

    PMID: 16443044BACKGROUND

  • 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.

    PMID: 10716457BACKGROUND

MeSH Terms

Conditions

Ventricular Remodeling

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Yara Amir, Resident Dr

CONTACT

+201064010505yaraamir2311@gmail.com

Hamdy Shams-eddin Mohammad, Assistant Pr

CONTACT

+201065601161ashams98@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 25, 2019

Study Start

May 1, 2019

Primary Completion

May 1, 2020

Study Completion

June 1, 2020

Last Updated

March 25, 2019

Record last verified: 2019-03