Acute Myocardial InfarctionNCT03905187
Stress Management Modified Cardiac Rehabilitation in Patients After Acute Myocardial Infarction or Heart Failure
A study testing Modified CR, Traditional CR and Education in people with Acute Myocardial Infarction and Heart Failure, run by Jing Ma at 1 site in China.
Trial summary
The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction, Heart Failure
- What is being tested?
- Modified CR, Traditional CR and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2019to 1 Sep 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years old with a diagnosis of AMI (include ST segment elevated myocardial infarction and non-ST segment elevated myocardial infarction) or heart failure
Who cannot join
- Uncontrolled tachycardia (heart rate at rest >120bpm
- Uncontrolled polypnea（breath rate at rest >30 breath per minute
- Uncontrolled respiratory failure （SPO2 ≤90%）
- Uncontrolled hypertension （pre-exercise SBP>180mmHg or DBP>110mmHg）
- Weight change in 72 hours >1.8kg
- Uncontrolled hyperglycemia (Random blood glucose>18mmol/L)
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- Uncontrolled malignant arrhythmia with hemodynamic instability
- Unoperated pseudoaneurysm、artery dissection
- Uncontrolled septic shock and septicopyemia
- Unoperated severe valvular heart disease or acute phase of heart failure caused by myocardial heart disease
- nervous system disease, motor system diseases and rheumatic diseases considered possibly worsened by exercise
- Uncooperation of the patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Perspective Randomized Study of Impact of Stress Management Involved Cardiac Rehabilitation on Psychological States and Clinical Outcomes of Patients After Acute Myocardial Infarction or Heart Failure
The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure.
Read the detailed description
The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure. The investigators performed modified cardiac rehabilitation program involving stress management on the patients who suffered from acute myocardial infarction or severe heart failure who were admitted to the CCU. Then the psychological states, quality of life and clinical outcomes were followed up.
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Being tested
- Modified CR, Traditional CR, Education
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified CRBehavioural
Stress management involved modified cardiac rehabilitation
Traditional CRBehavioural
Traditional cardiac rehabilitation
EducationBehavioural
Education
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Group received education only Receives: Behavioral: Education |
| Traditional CR Group | Other | Group received cardiac rehabilitation including education and exercise Receives: Behavioral: Traditional CR |
| Stress-Modified CR Group | Experimental | Group received cardiac rehabilitation including education, exercise and stress management Receives: Behavioral: Modified CR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score of anxiety test questionnaire decreased
The score of anxiety test questionnaire(Generalized Anxiety Disorder,GAD-7, normal range 0-21, partially reflecting the severity of anxiety with the higher score) decreased
Measured: 6 month
The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased
The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (abbreviation form is 36-Item Short Form Survey) increased. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability, The sections consists of Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, and Mental health. The total score of SF 36 Health survey is higher, the quality of life is higher.
Measured: 6 month
The score of patient health questionnaire decreased
The score of patient health questionnaire (PHQ9, normal range 0-27，indicating the profile of depression with the higher score) decreased
Measured: 6 month
The score of Chinese perceived stress scale decreased.
The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased.
Measured: 6 month
Secondary outcomes (4)
incidence of MACE in patients after acute myocardial infarction
any incidence of the following: death, cardiac death, AMI, revascularization, stroke
Measured: 6 month
incidence of MACE in patients with heart failure
death, cardiac death, resynchronization
Measured: 6 month
improvement of exercise capacity
6 minute walking distance
Measured: 6 month
incidence of rehospitalization
incidence of rehospitalization
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start16 Apr 2019 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Ma, Chinese PLA General Hospital
- Investigators
- Jing Ma, Principal investigator, Department of Cardiology in Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905187
- Sponsor's protocol ID
- 301CRS20181228
- Status last verified
- Apr 2019
- First submitted
- 3 Feb 2019
- Last updated
- 10 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Perspective Randomized Study of Impact of Stress Management Involved Cardiac Rehabilitation on Psychological States and Clinical Outcomes of Patients After Acute Myocardial Infarction or Heart Failure
- ClinicalTrials.gov ID
- NCT03905187
- Acronym / sponsor ID
- 301CRS20181228
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Jing MaUniversity, hospital or other
- Study start
- 16 Apr 2019 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 5 Apr 2019 (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.
The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure.
Detailed description
The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure. The investigators performed modified cardiac rehabilitation program involving stress management on the patients who suffered from acute myocardial infarction or severe heart failure who were admitted to the CCU. Then the psychological states, quality of life and clinical outcomes were followed up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Behavioral: EducationGroup received education only |
| Traditional CR Group | Other | Behavioral: Traditional CRGroup received cardiac rehabilitation including education and exercise |
| Stress-Modified CR Group | Experimental | Behavioral: Modified CRGroup received cardiac rehabilitation including education, exercise and stress management |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-80 years old with a diagnosis of AMI (include ST segment elevated myocardial infarction and non-ST segment elevated myocardial infarction) or heart failure
Key exclusion criteria (12 listed)
- Uncontrolled tachycardia (heart rate at rest >120bpm
- Uncontrolled polypnea（breath rate at rest >30 breath per minute
- Uncontrolled respiratory failure （SPO2 ≤90%）
- Uncontrolled hypertension （pre-exercise SBP>180mmHg or DBP>110mmHg）
- Weight change in 72 hours >1.8kg
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 |
|---|---|---|
| Modified CRStress management involved modified cardiac rehabilitation | Behavioural | Stress-Modified CR Group |
| Traditional CRTraditional cardiac rehabilitation | Behavioural | Traditional CR Group |
| EducationEducation | Behavioural | Control Group |
Primary outcome
The score of anxiety test questionnaire decreased
Time frame: 6 month
The score of anxiety test questionnaire(Generalized Anxiety Disorder,GAD-7, normal range 0-21, partially reflecting the severity of anxiety with the higher score) decreased
The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased
Time frame: 6 month
The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (abbreviation form is 36-Item Short Form Survey) increased. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability, The sections consists of Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, and Mental health. The total score of SF 36 Health survey is higher, the quality of life is higher.
The score of patient health questionnaire decreased
Time frame: 6 month
The score of patient health questionnaire (PHQ9, normal range 0-27，indicating the profile of depression with the higher score) decreased
The score of Chinese perceived stress scale decreased.
Time frame: 6 month
The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased.
4 secondary outcomes
incidence of MACE in patients after acute myocardial infarction
Time frame: 6 month
incidence of MACE in patients with heart failure
Time frame: 6 month
improvement of exercise capacity
Time frame: 6 month
incidence of rehospitalization
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Jing Ma principal investigator
Department of Cardiology in Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified CR, Traditional CR and Education in people with Acute Myocardial Infarction and Heart Failure, run by Jing Ma at 1 site in China.
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 12 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 10 Apr 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 China. 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 Jing Ma (+8613681257396, crystalma@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score of anxiety test questionnaire decreased (time frame: 6 month). The study lists 4 primary outcomes in all. 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 10 Apr 2019.