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ST-segment Elevation Myocardial Infarction (STEMI)NCT04549766

Predictive Value of PRECISE DAPT Score in STEMI Patients After Primary PCI

An observational study of ST-segment Elevation Myocardial Infarction (STEMI), run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
calculate PRECISE DAPT score using clinical data
How many people
150 participants
Where
No sites listed yet
Study dates
Sep 2020to Oct 2025
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
  • No healthy volunteers
  • Adult, Older adult

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)

Inclusion Criteria:1.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.[11].

2..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]

-

Exclusion Criteria:1-late presentation with STEMI more than 12 hr \& door to ballon more than 120 min including rescue PCI .

2- 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 .

-

Trial locations and contacts

No sites are listed yet.

Madonna Atef, Resident contact

01012767967

donna.atef555@gmail.com

Hatem Abd-Elrahman, Professor contact

01005212162

hatem19652007@yahoo.com

About this study

Official title: The Predictive Value of PRECISE DAPT Score in Patients With ST Segment Elevation Myocardial Infarction (STEMI) After Primary Percutaneous Coronary Intervention (PPCI)

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 .

Read the detailed description

Coronary artery disease (CAD) is the leading cause of death around the world and more than 4 million people die every year due to CAD in Europe.[1] The incidence of ST elevation myocardial infarction (STEMI) appears to be declining; however, it is still an important issue in cardiovascular medicine.[2] Initial risk assessment is important for STEMI to estimate adverse cardiovascular outcomes. Previous studies demonstrated that increased age, advanced Killip class, heart rate, arterial hypotension, increased serum creatinine, white blood cell counts, and hemoglobin levels were predictors of in-hospital and early mortality in patients with STEMI treated with primary percutaneous coronary intervention (PPCI).[3,4 ]Therefore, risk scores including the aforementioned parameters were developed to estimate mortality in patients with STEMI.

No-reflow is still a challenging major issue in the management of the patients with STEMI undergoing primary PCI. It is defined as inadequate myocardial perfusionthrough a given segment of the coronary circulation without angiographic evidence of mechanical vessel obstructionas [5] Angiographic no-reflow defined as less than Thrombolysis In Myocardial Infarction (TIMI) 3 flow [6] and angiographic success was defined as TIMI Grade 3 Flow .

PRECISE-DAPT score includes age, creatinine clearance, white blood cell counts, hemoglobin levels, and prior spontaneous bleeding [7]. All these factors have a close relationship with coronary artery disease (CAD) and complications [8-10]. Therefore, in this study, we aimed to evaluate the association of admission PRECISE-DAPT score with the development of slow flow \& bleeding \& othershort term cardiovascular complications that develop in patients with STEMI treated with primary PCI.

Being tested
calculate PRECISE DAPT score using clinical data
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • calculate PRECISE DAPT score using clinical dataOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Secondary outcomes (1)

  1. Predictive value of PRECISE DAPT score

    Whether there is relation between PRECISE DAPT score \&post PPCI short term complications or not

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study startSep 2020 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

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
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04549766
Sponsor's protocol ID
PRECISE DAPT score
Status last verified
Sep 2020
First submitted
9 Sep 2020
Last updated
16 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Townsend N, Wilson L, Bhatnagar P, Wickramasinghe K, Rayner M, Nichols M. Cardiovascular disease in Europe: epidemiological update 2016. Eur Heart J. 2016 Nov 7;37(42):3232-3245. doi: 10.1093/eurheartj/ehw334. Epub 2016 Aug 14. No abstract available.

    PubMed 27523477

  • 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.

    PubMed 19933242

  • 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.

    PubMed 21307002

  • 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.

    PubMed 22928184

  • 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.

    PubMed 4140198

  • 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.

    PubMed 7717278

  • 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.

    PubMed 28290994

  • 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.

    PubMed 14740503

  • 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.

    PubMed 19417195

  • 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.

    PubMed 22044033

  • 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.

    PubMed 30153967

  • 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.

    PubMed 10341277

  • 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.

    PubMed 28886622

  • 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.]

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

Questions about this trial

What is this clinical trial studying?

An observational study of ST-segment Elevation Myocardial Infarction (STEMI), 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?

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 16 Sep 2020. 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 Madonna Atef, Resident (01012767967, donna.atef555@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Follow up complications after PPCI (time frame: 3 months). 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 NCT04549766, which also lists 21 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 16 Sep 2020.

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