Coronary Anatomy Study and Times Since the Onset of Acute Myocardial Infarction Symptoms in Women Until the Opening of the Artery (TAPAC Study)
TAPAC
1 other identifier
observational
800
1 country
1
Brief Summary
TAPAC study is an an investigator-driven, observational, prospective,cohort aimed at evaluating differences between men and women in patients undergoing primary angioplasty : hospital medical care, successful markers myocardial reperfusion and the anatomical substrate by describing the underlying coronary anatomy will be compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2017
CompletedFirst Posted
Study publicly available on registry
May 12, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2019
CompletedFebruary 27, 2019
February 1, 2019
1.3 years
May 4, 2017
February 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Door-to-balloon time in patients
Door-to-balloon time in patients
90 minutes
Door-to-needle time in patients
Door-to-balloon time in patients
90 minutes
Time from onset of chest pain to first medical care
Time from onset of chest pain to first medical care
24 hours
Time from onset of chest pain to arrival Cath Lab
Time from onset of chest pain to arrival Cath Lab
24 hours
Time from onset of chest pain to artery opening
Time from onset of chest pain to artery opening
24 hours
Markers successful myocardial reperfusion by angiography
ST segment resolution 90 minutes post-PCI (Percutaneous Coronary Intervention)
First 90 min after reperfusion.
Markers successful myocardial reperfusion by angiography
Final TIMI (Thrombolysis in Myocardial Infarction) flow grade
First 90 min after reperfusion.
Markers successful myocardial reperfusion by angiography
Final TIMI blush grade
First 90 min after reperfusion.
Underlying coronary anatomy assessment
Final TIMI Thrombus grade
24 hours
Underlying coronary anatomy assessment
Degree of difuse disease
24 hours
Underlying coronary anatomy assessment
Number of vessels involve
24 hours
Underlying coronary anatomy assessment
Percentage of Ventricular Ejection Fraction
24 hours
Underlying coronary anatomy assessment
Presence of significant Left Main disease
24 hours
Underlying coronary anatomy assessment
Degree of distal embolization
24 hours
Secondary Outcomes (1)
Major adverse cardiac events (MACE)
Hospital discharge and expected average of 1 week, one year follow-up
Study Arms (2)
Women patients
Women patients
Men patients
Men patients
Interventions
Eligibility Criteria
Men and women undergoing coronary angioplasty.
You may qualify if:
- Patients with:
- Aged 18 years or over.
- AMI (Acute Mycardial Infarction ) with ST segment elevation and indication of primary angioplasty in whom at least one diagnostic procedure with coronary angiography is performed.
You may not qualify if:
- Patients with:
- Life expectancy of less than one year.
- Previous AMI.
- Previous coronary revascularization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Related Publications (5)
Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):447-54. doi: 10.1161/CIR.0000000000000366. No abstract available.
PMID: 26811276BACKGROUND2. World Health Organization.The European Health Report2012: Chartingthe Wayto Well-being. Copenhagen, Denmark: World Health Organization Regional Office for Europe;2012
BACKGROUNDDegano IR, Salomaa V, Veronesi G, Ferrieres J, Kirchberger I, Laks T, Havulinna AS, Ruidavets JB, Ferrario MM, Meisinger C, Elosua R, Marrugat J; Acute Myocardial Infarction Trends in Europe (AMITIE) Study Investigators. Twenty-five-year trends in myocardial infarction attack and mortality rates, and case-fatality, in six European populations. Heart. 2015 Sep;101(17):1413-21. doi: 10.1136/heartjnl-2014-307310. Epub 2015 Apr 8.
PMID: 25855798BACKGROUNDGarcia-Dorado D, Garcia del Blanco B. Door-to-balloon time and mortality. N Engl J Med. 2014 Jan 9;370(2):179. doi: 10.1056/NEJMc1313113. No abstract available.
PMID: 24401062BACKGROUNDPancholy SB, Shantha GP, Patel T, Cheskin LJ. Sex differences in short-term and long-term all-cause mortality among patients with ST-segment elevation myocardial infarction treated by primary percutaneous intervention: a meta-analysis. JAMA Intern Med. 2014 Nov;174(11):1822-30. doi: 10.1001/jamainternmed.2014.4762.
PMID: 25265319BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2017
First Posted
May 12, 2017
Study Start
November 1, 2017
Primary Completion
February 26, 2019
Study Completion
February 26, 2019
Last Updated
February 27, 2019
Record last verified: 2019-02