Acute Myocardial InfarctionNCT03638050
The Safety of the 6-minute Walk Test After Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction and Six-minute Walk Test, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Background: The six-minute walk test (6MWT) is widely used as an instrument for assessing the functional capacity of cardiac patients. It's a simple, low cost test that better reflects day-to-day activities when compared to other tests. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Six-minute Walk Test
- What is being tested?
- Functional Capacity Assessment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Aug 2016to Dec 2019
- 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
- Adult, Older adult
Study population: Sequential AMI patients admitted to hospitalization in the third day after myocardial infarction
Who may be able to join
- AMI patients
Who cannot join
- Previous history of AMI
- Recurrent or refractory pain
- Presence of neuromuscular diseases
- Acute or chronic lung diseases
- Inability to perform the functional test
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Graciana Santos Martinhão
São Paulo, 04024002
Investigator, 5511999297715
About this study
Background: The six-minute walk test (6MWT) is widely used as an instrument for assessing the functional capacity of cardiac patients. It's a simple, low cost test that better reflects day-to-day activities when compared to other tests. Its use to evaluate the functional capacity of cardiac patients in the in-hospital phase after acute myocardial infarction requires further studies. Objective: To evaluate the safety of the 6MWT performed on the third day after acute myocardial infarction (AMI). Methods: It's a cross-sectional study, to be accomplished in Hospital São Paulo - Federal University of Sao Paulo. Individuals, of both genders, aged 18 years and over, will be assessed on the third day after acute myocardial infarction. The 6MWT will be performed according to the norms of the American Thoracic Society. The distance covered during the 6MWT will be measured as weel as adverse events.
- Conditions
- Acute Myocardial Infarction, Six-minute Walk Test
- Being tested
- Functional Capacity Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Capacity AssessmentOther
Individuals will be assessed on the third day after acute myocardial infarction. The six-minute walk test will be performed according to the norms of the American Thoracic Society.
| Study group | Role | What they receive |
|---|---|---|
| In-hospital acute myocardial infarction patients | Functional Capacity Assessment Receives: Other: Functional Capacity Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test to measure functional capacity
By 6MWT assessing the functional capacity after acute myocardial infarction
Measured: Third day after acute myocardial infarction
Secondary outcomes (8)
Angina
To assess the occurrence of angina during the 6MWT
Measured: Third day after acute myocardial infarction
Dyspnea
To assess the occurrence of dyspnea during the 6MWT
Measured: Third day after acute myocardial infarction
Pallor
To assess the occurrence of pallor during the 6MWT
Measured: Third day after acute myocardial infarction
Sweating
To assess the occurrence of sweating during the 6MWT
Measured: Third day after acute myocardial infarction
Cramps
To assess the occurrence of cramps during the 6MWT
Measured: Third day after acute myocardial infarction
Lower limbs fatigue
To assess the occurrence of lower limbs fatigue during the 6MWT
Measured: Third day after acute myocardial infarction
Dizziness
To assess the occurrence of dizziness during the 6MWT
Measured: Third day after acute myocardial infarction
Hospitalization stay
Duration of stay in the hospital (in days) will be recorded.
Measured: Thirty days after acute myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start17 Aug 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Solange Guizilini, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638050
- Sponsor's protocol ID
- 58277816.7.0000.5505
- Status last verified
- Aug 2018
- First submitted
- 27 Jul 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of the 6-minute Walk Test After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03638050
- Acronym / sponsor ID
- 58277816.7.0000.5505
- Conditions
- Acute Myocardial Infarction, Six-minute Walk Test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 17 Aug 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Aug 2018 (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.
Background: The six-minute walk test (6MWT) is widely used as an instrument for assessing the functional capacity of cardiac patients. It's a simple, low cost test that better reflects day-to-day activities when compared to other tests. Its use to evaluate the functional capacity of cardiac patients in the in-hospital phase after acute myocardial infarction requires further studies. Objective: To evaluate the safety of the 6MWT performed on the third day after acute myocardial infarction (AMI). Methods: It's a cross-sectional study, to be accomplished in Hospital São Paulo - Federal University of Sao Paulo. Individuals, of both genders, aged 18 years and over, will be assessed on the third day after acute myocardial infarction. The 6MWT will be performed according to the norms of the American Thoracic Society. The distance covered during the 6MWT will be measured as weel as adverse events.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-hospital acute myocardial infarction patients | – | Other: Functional Capacity AssessmentFunctional Capacity Assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Sequential AMI patients admitted to hospitalization in the third day after myocardial infarction
Key inclusion criteria (1 listed)
- AMI patients
Key exclusion criteria (5 listed)
- Previous history of AMI
- Recurrent or refractory pain
- Presence of neuromuscular diseases
- Acute or chronic lung diseases
- Inability to perform the functional test
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 |
|---|---|---|
| Functional Capacity AssessmentIndividuals will be assessed on the third day after acute myocardial infarction. The six-minute walk test will be performed according to the norms of the American Thoracic Society. | Other | In-hospital acute myocardial infarction patients |
Primary outcome
Six-minute walk test to measure functional capacity
Time frame: Third day after acute myocardial infarction
By 6MWT assessing the functional capacity after acute myocardial infarction
8 secondary outcomes
Angina
Time frame: Third day after acute myocardial infarction
Dyspnea
Time frame: Third day after acute myocardial infarction
Pallor
Time frame: Third day after acute myocardial infarction
Sweating
Time frame: Third day after acute myocardial infarction
Cramps
Time frame: Third day after acute myocardial infarction
Lower limbs fatigue
Time frame: Third day after acute myocardial infarction
Dizziness
Time frame: Third day after acute myocardial infarction
Hospitalization stay
Time frame: Thirty days after acute myocardial infarction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
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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.
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 Acute Myocardial Infarction and Six-minute Walk Test, run by Federal University of São Paulo at 1 site in Brazil.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Aug 2018. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Solange Guizilini, PhD (5511982887753, s_guizilini@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk test to measure functional capacity (time frame: Third day after acute myocardial infarction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2018.