NCT04549766

Brief Summary

To investigate the predictive value of PRECISE DAPT score in relation to coronary slow flow \& other short term major adverse cardiovascular events (MACE) post PPCI .

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

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

Study Start

First participant enrolled

September 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

4 years

First QC Date

September 9, 2020

Last Update Submit

September 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Follow up complications after PPCI

    calculating PRECISE DAPT score and follow up patients for three months whether these complications as coronary slow flow \&primary MACE \&secondary MACE \&bleeding

    3 months

Secondary Outcomes (1)

  • Predictive value of PRECISE DAPT score

    3 months

Interventions

calculate PRECISE DAPT score using clinical data in STEMI patients after PPCI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects diagnosed as STEMI accordind to fourth universal definition with age range from 18 to 75 years underwent PPCI at cardiology hospital assiut university hospital eligible for PPCI with STEMI within 12 h of symptom onset, provided it can be performed expeditiously (i.e. 120 min from STEMI diagnosis)

You may qualify if:

  • Patients elegable for PPCI with STEMI within 12 h of symptom onset, provided it can be performed expeditiously (i.e. 120 min from STEMI diagnosis)\[12\]

You may not qualify if:

  • cardiogenic shock 3-Patients known to have autoimmune disease (e.g vasculitis ) 4- platelate count less than 100000 IU . 5- prothrombin concentration less than 60% 6- Patients taking triple anti thrombotics .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (21)

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    PMID: 27523477BACKGROUND
  • Widimsky P, Wijns W, Fajadet J, de Belder M, Knot J, Aaberge L, Andrikopoulos G, Baz JA, Betriu A, Claeys M, Danchin N, Djambazov S, Erne P, Hartikainen J, Huber K, Kala P, Klinceva M, Kristensen SD, Ludman P, Ferre JM, Merkely B, Milicic D, Morais J, Noc M, Opolski G, Ostojic M, Radovanovic D, De Servi S, Stenestrand U, Studencan M, Tubaro M, Vasiljevic Z, Weidinger F, Witkowski A, Zeymer U; European Association for Percutaneous Cardiovascular Interventions. Reperfusion therapy for ST elevation acute myocardial infarction in Europe: description of the current situation in 30 countries. Eur Heart J. 2010 Apr;31(8):943-57. doi: 10.1093/eurheartj/ehp492. Epub 2009 Nov 19.

    PMID: 19933242BACKGROUND
  • Yusufali A, Zubaid M, Al-Zakwani I, Alsheikh-Ali AA, Al-Mallah MH, Al Suwaidi J, AlMahmeed W, Rashed W, Sulaiman K, Amin H. Validation of the GRACE Risk score for hospital mortality in patients with acute coronary syndrome in the Arab Middle East. Angiology. 2011 Jul;62(5):390-6. doi: 10.1177/0003319710387921. Epub 2011 Feb 8.

    PMID: 21307002BACKGROUND
  • Puymirat E, Simon T, Steg PG, Schiele F, Gueret P, Blanchard D, Khalife K, Goldstein P, Cattan S, Vaur L, Cambou JP, Ferrieres J, Danchin N; USIK USIC 2000 Investigators; FAST MI Investigators. Association of changes in clinical characteristics and management with improvement in survival among patients with ST-elevation myocardial infarction. JAMA. 2012 Sep 12;308(10):998-1006. doi: 10.1001/2012.jama.11348.

    PMID: 22928184BACKGROUND
  • Kloner RA, Ganote CE, Jennings RB. The "no-reflow" phenomenon after temporary coronary occlusion in the dog. J Clin Invest. 1974 Dec;54(6):1496-508. doi: 10.1172/JCI107898.

    PMID: 4140198BACKGROUND
  • Abbo KM, Dooris M, Glazier S, O'Neill WW, Byrd D, Grines CL, Safian RD. Features and outcome of no-reflow after percutaneous coronary intervention. Am J Cardiol. 1995 Apr 15;75(12):778-82. doi: 10.1016/s0002-9149(99)80410-x.

    PMID: 7717278BACKGROUND
  • Costa F, van Klaveren D, James S, Heg D, Raber L, Feres F, Pilgrim T, Hong MK, Kim HS, Colombo A, Steg PG, Zanchin T, Palmerini T, Wallentin L, Bhatt DL, Stone GW, Windecker S, Steyerberg EW, Valgimigli M; PRECISE-DAPT Study Investigators. Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet. 2017 Mar 11;389(10073):1025-1034. doi: 10.1016/S0140-6736(17)30397-5.

    PMID: 28290994BACKGROUND
  • Zeidman A, Fradin Z, Blecher A, Oster HS, Avrahami Y, Mittelman M. Anemia as a risk factor for ischemic heart disease. Isr Med Assoc J. 2004 Jan;6(1):16-8.

    PMID: 14740503BACKGROUND
  • Mehta RH, Starr AZ, Lopes RD, Hochman JS, Widimsky P, Pieper KS, Armstrong PW, Granger CB; APEX AMI Investigators. Incidence of and outcomes associated with ventricular tachycardia or fibrillation in patients undergoing primary percutaneous coronary intervention. JAMA. 2009 May 6;301(17):1779-89. doi: 10.1001/jama.2009.600.

    PMID: 19417195BACKGROUND
  • Chatterjee S, Chandra P, Guha G, Kalra V, Chakraborty A, Frankel R, Shani J. Pre-procedural Elevated White Blood Cell Count and Neutrophil-Lymphocyte (N/L) Ratio are Predictors of Ventricular Arrhythmias During Percutaneous Coronary Intervention. Cardiovasc Hematol Disord Drug Targets. 2011;11(2):58-60. doi: 10.2174/187152911798346981.

    PMID: 22044033BACKGROUND
  • Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available.

    PMID: 30153967BACKGROUND
  • Thiemann DR, Coresh J, Oetgen WJ, Powe NR. The association between hospital volume and survival after acute myocardial infarction in elderly patients. N Engl J Med. 1999 May 27;340(21):1640-8. doi: 10.1056/NEJM199905273402106.

    PMID: 10341277BACKGROUND
  • Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available.

    PMID: 28886622BACKGROUND
  • 14-TIMI Flow Grade is scored from 0 to 3. It is a powerful predictor of outcome. Here shown are the findings from the TIMI 1 trial. TIMI, Thrombolysis in Myocardial Infarction. [Data from Flyngenring BP, Sheehan FH, Kennedy JW, Dodge HT, Braunwald E. Does arterial patency 90 minutes following thrombolytic therapy predict 42 day survival? J Am Coll Cardiol. 1991;17(Suppl A):275A.]

    BACKGROUND
  • 15- Gibson CM, Cannon CP, Daley WL; et al. (1996).

    BACKGROUND
  • 16 Gibson CM, Murphy SA, Rizzo MJ; et al. (1999).

    BACKGROUND
  • 17 - Gibson CM, Cannon CP, Murphy SA, Marble SJ, Barron HV, Braunwald E (2002).

    BACKGROUND
  • 18- January 2012Cardiology International 13(3):98-101

    BACKGROUND
  • 19-de Jong M, van der Worp HB, van der Graaf Y, Visseren FL, Westerink J (2017).

    BACKGROUND
  • Arnott C, Li Q, Kang A, Neuen BL, Bompoint S, Lam CSP, Rodgers A, Mahaffey KW, Cannon CP, Perkovic V, Jardine MJ, Neal B. Sodium-Glucose Cotransporter 2 Inhibition for the Prevention of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2020 Feb 4;9(3):e014908. doi: 10.1161/JAHA.119.014908. Epub 2020 Jan 29.

    PMID: 31992158BACKGROUND
  • Ndrepepa G, Schuster T, Hadamitzky M, Byrne RA, Mehilli J, Neumann FJ, Richardt G, Schulz S, Laugwitz KL, Massberg S, Schomig A, Kastrati A. Validation of the Bleeding Academic Research Consortium definition of bleeding in patients with coronary artery disease undergoing percutaneous coronary intervention. Circulation. 2012 Mar 20;125(11):1424-31. doi: 10.1161/CIRCULATIONAHA.111.060871. Epub 2012 Feb 17.

    PMID: 22344040BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Aly Mohamed, Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madonna Atef, Resident

CONTACT

Hatem Abd-Elrahman, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 16, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2024

Study Completion

October 1, 2025

Last Updated

September 16, 2020

Record last verified: 2020-09