Clinical trial NCT03152240: Coronary Anatomy Study and Times Since the Onset of Acute Myocardial Infarction Symptoms in Women Until the Opening of the Artery (TAPAC Study)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: Acute Coronary Syndrome
Primary Angioplasty
Gender
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women undergoing coronary angioplasty.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Door-to-balloon time in patients
timeFrame: 90 minutes
measure: Door-to-needle time in patients
timeFrame: 90 minutes
measure: Time from onset of chest pain to first medical care
timeFrame: 24 hours
measure: Time from onset of chest pain to arrival Cath Lab
timeFrame: 24 hours
measure: Time from onset of chest pain to artery opening
timeFrame: 24 hours
measure: Markers successful myocardial reperfusion by angiography
timeFrame: First 90 min after reperfusion.
measure: Markers successful myocardial reperfusion by angiography
timeFrame: First 90 min after reperfusion.
measure: Markers successful myocardial reperfusion by angiography
timeFrame: First 90 min after reperfusion.
measure: Underlying coronary anatomy assessment
timeFrame: 24 hours
measure: Underlying coronary anatomy assessment
timeFrame: 24 hours
measure: Underlying coronary anatomy assessment
timeFrame: 24 hours
measure: Underlying coronary anatomy assessment
timeFrame: 24 hours
measure: Underlying coronary anatomy assessment
timeFrame: 24 hours
measure: Underlying coronary anatomy assessment
timeFrame: 24 hours
Secondary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: Hospital discharge and expected average of 1 week, one year follow-up
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
References:
citation: 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.
citation: 2. World Health Organization.The European Health Report2012: Chartingthe Wayto Well-being. Copenhagen, Denmark: World Health Organization Regional Office for Europe;2012
citation: Degano 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.
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. No abstract available.
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.