Coronary Artery DiseaseNCT00713557
Shanghai Registry of Acute Coronary Events
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
SRACE is an multicenter observational database of outcomes for patients who are hospitalized with an acute coronary events. SRACE includes over 20 hospitals in Shanghai China that have enrolled a total of more than 3,000 patients since 2005, with an annual enrollment of 500 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- drug-eluting stent and Tirofiban
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- Mar 2005to Jan 2018
- 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: patients admitted to the hospital with acute coronary syndrome
Who may be able to join
- patients admitted to the hospital with acute coronary syndrome and received medical or interventional treatment
Who cannot join
- non ACS patients;
- complicated with other lethal disease
- predicted life span less than 12 months
- known allergy history to any anti-platelet or anti-thrombin medicine
- unconscious at the time of arrival at the hospital
Trial locations and contacts
1 site in 1 country.
China1 site
Dept. of Cardiology, Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Phase 4 Study to Compare Different Therapeutic Strategies for Patients With ACS
SRACE is an multicenter observational database of outcomes for patients who are hospitalized with an acute coronary events. SRACE includes over 20 hospitals in Shanghai China that have enrolled a total of more than 3,000 patients since 2005, with an annual enrollment of 500 patients. The major purpose of the SRACE program is to evaluate the prognosis of patients admitted to the hospital due to acute coronary events, comparing different therapeutic strategies, in-hospital transferring system, and so on. All participating physicians receive confidential quarterly reports showing ther outcomes side-by-side with the aggregate outcomes of all participating hospitals.
Read the detailed description
consecutive patients with STEMI who presented symptoms within 12 hours and treated by primary PCI in Shanghai, were enrolled in the prospective sysytem. Several strategies were applied in these patients, including physician vs. patient transfer strategy, upsteam vs. downstream strategy, Firebird stent vs. Excel stent (bio-absorbable SES), etc. Once the patient was randomized to one of these study, he will be denied to the others. Clinical and angiographic outcomes were compared, with the final purpose to find an optimal strategy in treating AMI patients.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Being tested
- drug-eluting stent, Tirofiban
- Keywords
- coronary angioplasty
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug-eluting stentDevice
Also called Cypher stent, Taxus stent, Firebird stent, Excel stent
drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent
TirofibanDrug
upstream (in emergency room) versus downstream (in catheterization lab) intra-coronary loading versus conventional intravenous loading
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients with acute ST-elevation myocardial infarction and receiving primary percutaneous coronary intervention Subgroup: Patient Transferring vs. Physician Transferring strategy Receives: Device: drug-eluting stent | |
| 2 | patients with acute ST-elevation myocardial infarction treated by thrombolysis or facilitated PCI Subgroup: upstream use of Tirofiban + primary PCI vs. downstream use of tirofiban + primary PCI Receives: Device: drug-eluting stent; Drug: Tirofiban | |
| 3 | patients with non-ST-elevation ACS treated by immediate PCI Receives: Device: drug-eluting stent | |
| 4 | patients with non ST-elevation ACS treated by elective PCI Receives: Device: drug-eluting stent | |
| 5 | STEMI patient with multivessel disease, complete revascularization is planned to achieve during the index hospitalization.i.e.P-PCI for culprit lesion,combined with staged PCI for remaining diseased vessel. | |
| 6 | STEMI patient with multivessel disease, complete revascularization is planned to achieve at 6 weeks after STEMI onset.i.e.P-PCI for culprit lesion during index hospitalization,combined with staged PCI for remaining diseased vessel at 6-week's follow-up(secondary hospitalization). |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac events(MACE), including death, non-fatal re-MI, and target vessel revascularization
Measured: in-hospital, 30d, and long-term follow-up
Secondary outcomes (1)
stroke, stent thrombosis
Measured: in-hospital, 30d, and long-term follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startMar 2005
- Primary completionJan 2018 (estimated)
Why it stopped: devices applied in the study were no more available in the market, and medical intervention section was completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China, Changhai Hospital
- Responsible party
- Principal investigator, Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine
- Investigators
- Wei Feng Shen, MD,PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713557
- Sponsor's protocol ID
- RJH
- Status last verified
- Oct 2016
- First submitted
- 7 Jul 2008
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang Q, Zhang RY, Qiu JP, Zhang JF, Wang XL, Jiang L, Liao ML, Zhang JS, Hu J, Yang ZK, Shen WF. Prospective multicenter randomized trial comparing physician versus patient transfer for primary percutaneous coronary intervention in acute ST-segment elevation myocardial infarction. Chin Med J (Engl). 2008 Mar 20;121(6):485-91.
PubMed 18364130Zhang Q, Zhang RY, Qiu JP, Zhang JF, Wang XL, Jiang L, Liao ML, Zhang JS, Hu J, Yang ZK, Shen WF. One-year clinical outcome of interventionalist- versus patient-transfer strategies for primary percutaneous coronary intervention in patients with acute ST-segment elevation myocardial infarction: results from the REVERSE-STEMI study. Circ Cardiovasc Qual Outcomes. 2011 May;4(3):355-62. doi: 10.1161/CIRCOUTCOMES.110.958785. Epub 2011 Apr 26.
PubMed 21521833Qiu JP, Zhang Q, Lu JD, Wang HR, Lin J, Ge ZR, Zhang RY, Shen WF. Direct ambulance transport to catheterization laboratory reduces door-to-balloon time in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: the DIRECT-STEMI study. Chin Med J (Engl). 2011 Mar;124(6):805-10.
PubMed 21518584Zhang Q, Qiu JP, Kirtane AJ, Zhu TQ, Zhang RY, Yang ZK, Hu J, Ding FH, DU R, Shen WF. Comparison of biodegradable polymer versus durable polymer sirolimus-eluting stenting in patients with acute st-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of the RESOLVE study. J Interv Cardiol. 2014 Apr;27(2):131-41. doi: 10.1111/joic.12102.
PubMed 24697948
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study to Compare Different Therapeutic Strategies for Patients With ACS
- ClinicalTrials.gov ID
- NCT00713557
- Acronym / sponsor ID
- RJH
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome
- Keywords
- coronary angioplasty
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: devices applied in the study were no more available in the market, and medical intervention section was completed.
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China, Changhai Hospital
- Study start
- Mar 2005
- Primary completion
- Jan 2018 (estimated)
- First posted
- 11 Jul 2008 (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.
SRACE is an multicenter observational database of outcomes for patients who are hospitalized with an acute coronary events. SRACE includes over 20 hospitals in Shanghai China that have enrolled a total of more than 3,000 patients since 2005, with an annual enrollment of 500 patients. The major purpose of the SRACE program is to evaluate the prognosis of patients admitted to the hospital due to acute coronary events, comparing different therapeutic strategies, in-hospital transferring system, and so on. All participating physicians receive confidential quarterly reports showing ther outcomes side-by-side with the aggregate outcomes of all participating hospitals.
Detailed description
consecutive patients with STEMI who presented symptoms within 12 hours and treated by primary PCI in Shanghai, were enrolled in the prospective sysytem. Several strategies were applied in these patients, including physician vs. patient transfer strategy, upsteam vs. downstream strategy, Firebird stent vs. Excel stent (bio-absorbable SES), etc. Once the patient was randomized to one of these study, he will be denied to the others. Clinical and angiographic outcomes were compared, with the final purpose to find an optimal strategy in treating AMI patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: drug-eluting stentpatients with acute ST-elevation myocardial infarction and receiving primary percutaneous coronary intervention Subgroup: Patient Transferring vs. Physician Transferring strategy |
| 2 | – | Device: drug-eluting stent, Drug: Tirofibanpatients with acute ST-elevation myocardial infarction treated by thrombolysis or facilitated PCI Subgroup: upstream use of Tirofiban + primary PCI vs. downstream use of tirofiban + primary PCI |
| 3 | – | Device: drug-eluting stentpatients with non-ST-elevation ACS treated by immediate PCI |
| 4 | – | Device: drug-eluting stentpatients with non ST-elevation ACS treated by elective PCI |
| 5 | – | –STEMI patient with multivessel disease, complete revascularization is planned to achieve during the index hospitalization.i.e.P-PCI for culprit lesion,combined with staged PCI for remaining diseased vessel. |
| 6 | – | –STEMI patient with multivessel disease, complete revascularization is planned to achieve at 6 weeks after STEMI onset.i.e.P-PCI for culprit lesion during index hospitalization,combined with staged PCI for remaining diseased vessel at 6-week's follow-up(secondary hospitalization). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to the hospital with acute coronary syndrome
Key inclusion criteria (1 listed)
- patients admitted to the hospital with acute coronary syndrome and received medical or interventional treatment
Key exclusion criteria (5 listed)
- non ACS patients;
- complicated with other lethal disease
- predicted life span less than 12 months
- known allergy history to any anti-platelet or anti-thrombin medicine
- unconscious at the time of arrival at the hospital
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 |
|---|---|---|
| drug-eluting stentAlso: Cypher stent, Taxus stent, Firebird stent, Excel stentdrug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent | Device | 1, 2, 3, 4 |
| Tirofibanupstream (in emergency room) versus downstream (in catheterization lab) intra-coronary loading versus conventional intravenous loading | Drug | 2 |
Primary outcome
major adverse cardiac events(MACE), including death, non-fatal re-MI, and target vessel revascularization
Time frame: in-hospital, 30d, and long-term follow-up
1 secondary outcome
stroke, stent thrombosis
Time frame: in-hospital, 30d, and long-term follow-up
Results and safety
The study was stopped early (reason given: devices applied in the study were no more available in the market, and medical intervention section was completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Results publication: PubMed 18364130Zhang Q, Zhang RY, Qiu JP, Zhang JF, Wang XL, Jiang L, Liao ML, Zhang JS, Hu J, Yang ZK, Shen WF. Prospective multicenter randomized trial comparing physician versus patient transfer for primary percutaneous coronary intervention in acute ST-segment elevation myocardial infarction. Chin Med J (Engl). 2008 Mar 20;121(6):485-91.
- Results publication: PubMed 21521833Zhang Q, Zhang RY, Qiu JP, Zhang JF, Wang XL, Jiang L, Liao ML, Zhang JS, Hu J, Yang ZK, Shen WF. One-year clinical outcome of interventionalist- versus patient-transfer strategies for primary percutaneous coronary intervention in patients with acute ST-segment elevation myocardial infarction: results from the REVERSE-STEMI study. Circ Cardiovasc Qual Outcomes. 2011 May;4(3):355-62. doi: 10.1161/CIRCOUTCOMES.110.958785. Epub 2011 Apr 26.
- Results publication: PubMed 21518584Qiu JP, Zhang Q, Lu JD, Wang HR, Lin J, Ge ZR, Zhang RY, Shen WF. Direct ambulance transport to catheterization laboratory reduces door-to-balloon time in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: the DIRECT-STEMI study. Chin Med J (Engl). 2011 Mar;124(6):805-10.
- Derived from this study: PubMed 24697948Zhang Q, Qiu JP, Kirtane AJ, Zhu TQ, Zhang RY, Yang ZK, Hu J, Ding FH, DU R, Shen WF. Comparison of biodegradable polymer versus durable polymer sirolimus-eluting stenting in patients with acute st-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of the RESOLVE study. J Interv Cardiol. 2014 Apr;27(2):131-41. doi: 10.1111/joic.12102.
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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.
Wei Feng Shen, MD,PhD principal investigator
Ruijin Hospital
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 Coronary Artery Disease and Acute Coronary Syndrome, run by Shanghai Jiao Tong University School of Medicine 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 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: stopped early, as of the sponsor's last update on 13 Oct 2016. 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?
The study was stopped early (reason given: devices applied in the study were no more available in the market, and medical intervention section was completed.). Results are not available in the source record.
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?
major adverse cardiac events(MACE), including death, non-fatal re-MI, and target vessel revascularization (time frame: in-hospital, 30d, and long-term follow-up). 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 NCT00713557, which also lists 4 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 13 Oct 2016.