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

Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03152240
Collaborator
(none)
800
1
15.8
50.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
800 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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)
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Feb 26, 2019
Actual Study Completion Date :
Feb 26, 2019

Arms and Interventions

Arm Intervention/Treatment
Women patients

Women patients

Other: Non intervention
Non intervention

Men patients

Men patients

Other: Non intervention
Non intervention

Outcome Measures

Primary Outcome Measures

  1. Door-to-balloon time in patients [90 minutes]

    Door-to-balloon time in patients

  2. Door-to-needle time in patients [90 minutes]

    Door-to-balloon time in patients

  3. Time from onset of chest pain to first medical care [24 hours]

    Time from onset of chest pain to first medical care

  4. Time from onset of chest pain to arrival Cath Lab [24 hours]

    Time from onset of chest pain to arrival Cath Lab

  5. Time from onset of chest pain to artery opening [24 hours]

    Time from onset of chest pain to artery opening

  6. Markers successful myocardial reperfusion by angiography [First 90 min after reperfusion.]

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

  7. Markers successful myocardial reperfusion by angiography [First 90 min after reperfusion.]

    Final TIMI (Thrombolysis in Myocardial Infarction) flow grade

  8. Markers successful myocardial reperfusion by angiography [First 90 min after reperfusion.]

    Final TIMI blush grade

  9. Underlying coronary anatomy assessment [24 hours]

    Final TIMI Thrombus grade

  10. Underlying coronary anatomy assessment [24 hours]

    Degree of difuse disease

  11. Underlying coronary anatomy assessment [24 hours]

    Number of vessels involve

  12. Underlying coronary anatomy assessment [24 hours]

    Percentage of Ventricular Ejection Fraction

  13. Underlying coronary anatomy assessment [24 hours]

    Presence of significant Left Main disease

  14. Underlying coronary anatomy assessment [24 hours]

    Degree of distal embolization

Secondary Outcome Measures

  1. Major adverse cardiac events (MACE) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitari Vall d'Hebron Barcelona Spain 08035

Sponsors and Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT03152240
Other Study ID Numbers:
  • TAPAC study
First Posted:
May 12, 2017
Last Update Posted:
Feb 27, 2019
Last Verified:
Feb 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 27, 2019