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NCT Number: NCT03152240

Coronary Anatomy Study and Times Since the Onset of Acute Myocardial 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.

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Key information

Conditions

Myocardial Infarction Acute Coronary Syndrome Behavior Cardiovascular Diseases Coitus Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Behavior Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non intervention

Other

Non intervention

Primary outcomes

  1. Door-to-balloon time in patients

    Time frame: 90 minutes

    Door-to-balloon time in patients

  2. Door-to-needle time in patients

    Time frame: 90 minutes

    Door-to-balloon time in patients

  3. Time from onset of chest pain to first medical care

    Time frame: 24 hours

    Time from onset of chest pain to first medical care

  4. Time from onset of chest pain to arrival Cath Lab

    Time frame: 24 hours

    Time from onset of chest pain to arrival Cath Lab

  5. Time from onset of chest pain to artery opening

    Time frame: 24 hours

    Time from onset of chest pain to artery opening

  6. Markers successful myocardial reperfusion by angiography

    Time frame: First 90 min after reperfusion.

    ST segment resolution 90 minutes post-PCI (Percutaneous Coronary Intervention)

  7. Markers successful myocardial reperfusion by angiography

    Time frame: First 90 min after reperfusion.

    Final TIMI (Thrombolysis in Myocardial Infarction) flow grade

  8. Markers successful myocardial reperfusion by angiography

    Time frame: First 90 min after reperfusion.

    Final TIMI blush grade

  9. Underlying coronary anatomy assessment

    Time frame: 24 hours

    Final TIMI Thrombus grade

  10. Underlying coronary anatomy assessment

    Time frame: 24 hours

    Degree of difuse disease

  11. Underlying coronary anatomy assessment

    Time frame: 24 hours

    Number of vessels involve

  12. Underlying coronary anatomy assessment

    Time frame: 24 hours

    Percentage of Ventricular Ejection Fraction

  13. Underlying coronary anatomy assessment

    Time frame: 24 hours

    Presence of significant Left Main disease

  14. Underlying coronary anatomy assessment

    Time frame: 24 hours

    Degree of distal embolization

Secondary outcomes

  1. Major adverse cardiac events (MACE)

    Time frame: Hospital discharge and expected average of 1 week, one year follow-up

    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

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Acronym: TAPAC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 12, 2017
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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