Myocardial InfarctionTAPACNCT03152240
Coronary Anatomy Study and Times Since the Onset of Acute Myocardial Infarction Symptoms in Women Until the Opening of the Artery (TAPAC Study)
An observational study of Myocardial Infarction, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Non intervention
- How many people
- 800 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2017to 26 Feb 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women undergoing coronary angioplasty.
Who may be able to join
- 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.
Who cannot join
- Patients with:
- Life expectancy of less than one year.
- Previous AMI.
- Previous coronary revascularization.
Trial locations and contacts
1 site in 1 country.
About this 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)
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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- Non intervention
- Keywords
- Acute Coronary Syndrome, Primary Angioplasty, Gender
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionOther
Non intervention
| Study group | Role | What they receive |
|---|---|---|
| Women patients | Women patients Receives: Other: Non intervention | |
| Men patients | Men patients Receives: Other: Non intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Door-to-balloon time in patients
Door-to-balloon time in patients
Measured: 90 minutes
Door-to-needle time in patients
Door-to-balloon time in patients
Measured: 90 minutes
Time from onset of chest pain to first medical care
Time from onset of chest pain to first medical care
Measured: 24 hours
Time from onset of chest pain to arrival Cath Lab
Time from onset of chest pain to arrival Cath Lab
Measured: 24 hours
Time from onset of chest pain to artery opening
Time from onset of chest pain to artery opening
Measured: 24 hours
Markers successful myocardial reperfusion by angiography
ST segment resolution 90 minutes post-PCI (Percutaneous Coronary Intervention)
Measured: First 90 min after reperfusion.
Markers successful myocardial reperfusion by angiography
Final TIMI (Thrombolysis in Myocardial Infarction) flow grade
Measured: First 90 min after reperfusion.
Markers successful myocardial reperfusion by angiography
Final TIMI blush grade
Measured: First 90 min after reperfusion.
Underlying coronary anatomy assessment
Final TIMI Thrombus grade
Measured: 24 hours
Underlying coronary anatomy assessment
Degree of difuse disease
Measured: 24 hours
Underlying coronary anatomy assessment
Number of vessels involve
Measured: 24 hours
Underlying coronary anatomy assessment
Percentage of Ventricular Ejection Fraction
Measured: 24 hours
Underlying coronary anatomy assessment
Presence of significant Left Main disease
Measured: 24 hours
Underlying coronary anatomy assessment
Degree of distal embolization
Measured: 24 hours
Secondary outcomes (1)
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
Measured: Hospital discharge and expected average of 1 week, one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 Nov 2017
- Primary completion26 Feb 2019
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152240
- Sponsor's protocol ID
- TAPAC study
- Acronym
- TAPAC
- Status last verified
- Feb 2019
- First submitted
- 4 May 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 268112762. 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.
PubMed 25855798Garcia-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.
PubMed 24401062Pancholy 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.
PubMed 25265319
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03152240
- Acronym / sponsor ID
- TAPAC / TAPAC study
- Conditions
- Myocardial Infarction
- Keywords
- Acute Coronary Syndrome, Primary Angioplasty, Gender
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 26 Feb 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women patients | – | Other: Non interventionWomen patients |
| Men patients | – | Other: Non interventionMen patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women undergoing coronary angioplasty.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Life expectancy of less than one year.
- Previous AMI.
- Previous coronary revascularization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventionNon intervention | Other | Men patients, Women patients |
Primary outcome
Door-to-balloon time in patients
Time frame: 90 minutes
Door-to-balloon time in patients
Door-to-needle time in patients
Time frame: 90 minutes
Door-to-balloon time in patients
Time from onset of chest pain to first medical care
Time frame: 24 hours
Time from onset of chest pain to first medical care
Time from onset of chest pain to arrival Cath Lab
Time frame: 24 hours
Time from onset of chest pain to arrival Cath Lab
Time from onset of chest pain to artery opening
Time frame: 24 hours
Time from onset of chest pain to artery opening
Markers successful myocardial reperfusion by angiography
Time frame: First 90 min after reperfusion.
ST segment resolution 90 minutes post-PCI (Percutaneous Coronary Intervention)
Markers successful myocardial reperfusion by angiography
Time frame: First 90 min after reperfusion.
Final TIMI (Thrombolysis in Myocardial Infarction) flow grade
Markers successful myocardial reperfusion by angiography
Time frame: First 90 min after reperfusion.
Final TIMI blush grade
Underlying coronary anatomy assessment
Time frame: 24 hours
Final TIMI Thrombus grade
Underlying coronary anatomy assessment
Time frame: 24 hours
Degree of difuse disease
Underlying coronary anatomy assessment
Time frame: 24 hours
Number of vessels involve
Underlying coronary anatomy assessment
Time frame: 24 hours
Percentage of Ventricular Ejection Fraction
Underlying coronary anatomy assessment
Time frame: 24 hours
Presence of significant Left Main disease
Underlying coronary anatomy assessment
Time frame: 24 hours
Degree of distal embolization
1 secondary outcome
Major adverse cardiac events (MACE)
Time frame: Hospital discharge and expected average of 1 week, one year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Background: PubMed 26811276Writing 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.
- Background2. World Health Organization.The European Health Report2012: Chartingthe Wayto Well-being. Copenhagen, Denmark: World Health Organization Regional Office for Europe;2012
- Background: PubMed 25855798Degano 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.
- Background: PubMed 24401062Garcia-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.
- Background: PubMed 25265319Pancholy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Door-to-balloon time in patients (time frame: 90 minutes). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03152240, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.