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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Other: Non intervention

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.

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Men and women undergoing coronary angioplasty.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women patients	Other: Non intervention; Non intervention
Men patients	Other: Non intervention; Non intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

General Publications

• 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.
• 2. World Health Organization.The European Health Report2012: Chartingthe Wayto Well-being. Copenhagen, Denmark: World Health Organization Regional Office for Europe;2012
• 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. Erratum In: Heart. 2018 Aug;104(16):e2.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): February 26, 2019
• Study Completion (Actual): February 26, 2019

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Acute Coronary Syndrome; Gender; Primary Angioplasty
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: TAPAC study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No