Coronary Anatomy Study and Times Since the Onset of Acute Myocardial Infarction Symptoms in Women Until the Opening of the Artery (TAPAC Study)

Myocardial Infarction Clinical Trial

— TAPAC  

Official title:

Coronary Anatomy Study and Times Since the Onset of Acute MyocardiaI Infarction Symptoms in Women Until the Opening of the Artery (TAPAC Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152240
• Other study ID #: TAPAC study
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: February 26, 2019

Study information

• Verified date: February 2019
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: February 26, 2019
• Est. primary completion date: February 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

Patients with:

• Life expectancy of less than one year.

• Previous AMI.

• Previous coronary revascularization.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• Non intervention
Non intervention

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d`Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (5)

2. World Health Organization.The European Health Report2012: Chartingthe Wayto Well-being. Copenhagen, Denmark: World Health Organization Regional Office for Europe;2012

Dégano IR, Salomaa V, Veronesi G, Ferriéres 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. Erratum in: Heart. 2018 Aug;104(16):e2. — View Citation

Garcia-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. — View Citation

Pancholy 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. Review. — View Citation

Writing Group Members, Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jiménez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Door-to-balloon time in patients	Door-to-balloon time in patients	90 minutes
Primary	Door-to-needle time in patients	Door-to-balloon time in patients	90 minutes
Primary	Time from onset of chest pain to first medical care	Time from onset of chest pain to first medical care	24 hours
Primary	Time from onset of chest pain to arrival Cath Lab	Time from onset of chest pain to arrival Cath Lab	24 hours
Primary	Time from onset of chest pain to artery opening	Time from onset of chest pain to artery opening	24 hours
Primary	Markers successful myocardial reperfusion by angiography	ST segment resolution 90 minutes post-PCI (Percutaneous Coronary Intervention)	First 90 min after reperfusion.
Primary	Markers successful myocardial reperfusion by angiography	Final TIMI (Thrombolysis in Myocardial Infarction) flow grade	First 90 min after reperfusion.
Primary	Markers successful myocardial reperfusion by angiography	Final TIMI blush grade	First 90 min after reperfusion.
Primary	Underlying coronary anatomy assessment	Final TIMI Thrombus grade	24 hours
Primary	Underlying coronary anatomy assessment	Degree of difuse disease	24 hours
Primary	Underlying coronary anatomy assessment	Number of vessels involve	24 hours
Primary	Underlying coronary anatomy assessment	Percentage of Ventricular Ejection Fraction	24 hours
Primary	Underlying coronary anatomy assessment	Presence of significant Left Main disease	24 hours
Primary	Underlying coronary anatomy assessment	Degree of distal embolization	24 hours
Secondary	Major adverse cardiac events (MACE)	MACE rate during hospitalization, defined as death, non-fatal myocardial rupture, or appearance or worsening of heart failure during the hospitalization period and after 1 year of follow-up	Hospital discharge and expected average of 1 week, one year follow-up