Acute Myocardial InfarctionNCT01357096
Development and Efficacy Evaluation of Integrated Chronic Care and Health Promotion Model for Patients With Coronary Artery Disease in Taiwan
A study testing Integrated health care team and Traditional group in people with Acute Myocardial Infarction and Stable Angina, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The hypothesis of this project is to examine whether the integrated health care program as the intervention group can reduce the recurrence and mortality of coronary artery-related diseases than the traditional one as the comparison group. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Acute Myocardial Infarction, Stable Angina
- What is being tested?
- Integrated health care team and Traditional group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Jan 2012
- 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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients who suffered from acute myocardial infarction or stable angina with intervention (CABG or PTCA)
Who cannot join
- Age > 85 yrs old.
- Worse short-term prognosis (e.g.cancer, congestive heart failure NYHA IV)
- Any systemic disease which will limit the exercise program (e.g. bed-ridden stroke)
- Unable to participate in the trial due to any logic reasons
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
Tsung-Hsien Lin, MD, PHD, 88673121101 ext. 7741, lth@kmu.edu.tw
Sheng-Hsiung Sheu, MD
About this study
The hypothesis of this project is to examine whether the integrated health care program as the intervention group can reduce the recurrence and mortality of coronary artery-related diseases than the traditional one as the comparison group.
- Conditions
- Acute Myocardial Infarction, Stable Angina
- Being tested
- Integrated health care team, Traditional group
- Keywords
- intervention, CABG or PTCA
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated health care teamBehavioural
CAD education fryers, drugs counseling, diet intervention, individualized exercise program, body weight control, smoking cessation program, and distant CAD care monitoring
Traditional groupOther
CAD education fryers
| Study group | Role | What they receive |
|---|---|---|
| Comparison group | No intervention | Not described Receives: Other: Traditional group |
| Integrated health care team | Experimental | Not described Receives: Behavioral: Integrated health care team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death, non-fatal MI, non-fatal stroke, recurrent angina, emergency room (ER) visit due to any CV-related diseases or readmission due to any CV-related diseases confirmed by the physicians.
Measured: one year
Secondary outcomes (1)
BP, lipid, glucose, EBM drugs and self-care efficacy
- Blood pressure < 140/90 mmHg (< 130/80 mmHg in the diabetics and patients with chronic kidney disease)
- Hypercholesterolemia：LDL < 100 mg/dl
- Diabetic：HbA1c < 7%
- Smoking cessation rate
- Adherence rate of EBM medication including anti-platelet agent, beta-blocker, RAS blocker and lipid-lowering agent.
- Efficacy of self care
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (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.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357096
- Sponsor's protocol ID
- 990179
- Status last verified
- Jul 2010
- First submitted
- 18 May 2011
- Last updated
- 20 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Efficacy Evaluation of Integrated Chronic Care and Health Promotion Model for Patients With Coronary Artery Disease in Taiwan
- ClinicalTrials.gov ID
- NCT01357096
- Acronym / sponsor ID
- 990179
- Conditions
- Acute Myocardial Infarction, Stable Angina
- Keywords
- intervention, CABG or PTCA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- First posted
- 20 May 2011 (estimated)
- 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 hypothesis of this project is to examine whether the integrated health care program as the intervention group can reduce the recurrence and mortality of coronary artery-related diseases than the traditional one as the comparison group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison group | No intervention | Other: Traditional group |
| Integrated health care team | Experimental | Behavioral: Integrated health care team |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients who suffered from acute myocardial infarction or stable angina with intervention (CABG or PTCA)
Key exclusion criteria (4 listed)
- Age > 85 yrs old.
- Worse short-term prognosis (e.g.cancer, congestive heart failure NYHA IV)
- Any systemic disease which will limit the exercise program (e.g. bed-ridden stroke)
- Unable to participate in the trial due to any logic reasons
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 |
|---|---|---|
| Integrated health care teamCAD education fryers, drugs counseling, diet intervention, individualized exercise program, body weight control, smoking cessation program, and distant CAD care monitoring | Behavioural | Integrated health care team |
| Traditional groupCAD education fryers | Other | Comparison group |
Primary outcome
Death, non-fatal MI, non-fatal stroke, recurrent angina, emergency room (ER) visit due to any CV-related diseases or readmission due to any CV-related diseases confirmed by the physicians.
Time frame: one year
1 secondary outcome
BP, lipid, glucose, EBM drugs and self-care efficacy
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2011.
Related trials for Acute Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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?
A study testing Integrated health care team and Traditional group in people with Acute Myocardial Infarction and Stable Angina, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 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: status not confirmed, as of the sponsor's last update on 20 May 2011. 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 Taiwan. 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 Sheng-Hsiung Sheu, MD (88673121101 ext. 7741, Sheush@kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death, non-fatal MI, non-fatal stroke, recurrent angina, emergency room (ER) visit due to any CV-related diseases or readmission due to any CV-related diseases confirmed by the physicians. (time frame: one year). 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 May 2011.