Microvascular Coronary Artery DiseaseFlashIVNCT06118450

Clinical Trial for Evaluating the Effectiveness and Safety of Online caIMR in STEMI Patients

An observational study of Microvascular Coronary Artery Disease and STEMI, run by The Affiliated Hospital of Xuzhou Medical University at 8 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Microvascular Coronary Artery Disease, STEMI
What is being tested?: Non-intervention
How many people: 335 participants
Where: 8 sitesChina
Study dates: 1 Nov 2023to 31 May 2025
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Aged between 18 and 80, regardless of gender. Initially diagnosed as STEMI and underwent primary PCI.

Who may be able to join

Aged between 18 and 80, regardless of gender;
Initially diagnosed as STEMI and underwent primary PCI;
Voluntarily participated in this trial and signed the informed consent form.

Who cannot join

Coronary angiography shows that PCI is not suitable;
Past history of coronary artery bypass grafting (CABG);
Past history of heart failure;
Past history of myocardial infarction;
Primary or secondary cardiomyopathy or heart valve disease;
Patients with renal insufficiency (eGFR<30ml/min (1.73m^2)) or patients undergoing dialysis;

Show all 15Show fewer

Cardiogenic shock
Persistent left or right coronary ostium lesion after target vessel PCI;
Immediate effect of target vessel PCI is unsatisfactory [such as thrombolysis in myocardial infarction (TIMI) flow < grade 2, dissection that restricted blood flow, side branch occlusion (diameter>1.5mm), exist distal embolism or angiographically visible thrombus];
Target vessel exist coronary fistula or myocardial bridge (lumen constriction >50%);
The target vessel cannot clearly expose the lesion in two positions with an included angle ≥ 30 degrees;
Severe systemic infection
Patients with malignant wasting disease, with an estimated survival of less than 1 year;
The subject is participating in another clinical researches, and the primary endpoint has not been reached;
The investigator believes that the subject has other conditions that are not suitable for clinical trials.

Trial locations and contacts

8 sites in 1 country.

Lu Yuan contact

86-13952110901

luyuan329@163.com

City, postcode or hospital

Sites recruiting now only

8 sites in 1 country

China8 sites, 8 recruiting

Beijing Luhe Hospital.Capital Medical University
Beijing, Beijing Municipality
Guangyao Zhai
Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Li Jianping, PHD
Not yet recruiting
Huai'an First People's Hospital
Huai'an, Jiangsu
Zhang Xiwen
Not yet recruiting
The First People'S Hospital of Lianyungang
Lianyungang, Jiangsu
Yin Delu
Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002
Lu yuan, 86-13952110901
Recruiting
General Hospital of Xuzhou Mining Group
Xuzhou, Jiangsu
Qi chunmei
Not yet recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu
Li Zhenyong
Not yet recruiting
Xuzhou First People's Hospital
Xuzhou, Jiangsu
Wang Xiangzhi
Not yet recruiting

Other trials in China

About this study

Official title: A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Online Coronary Angiography-Derived Index of Microcirculatory Resistance in STEMI Patients (Flash IV)

Despite the success of restoration of epicardial blood flow by the primary percutaneous coronary intervention (PPCI), approximately a half of patients with ST-segment elevation myocardial infarction (STEMI) have failed myocardial reperfusion, as reflected by microvascular obstruction (MVO) and intramyocardial haemorrhage (IMH). The coronary angiography-derived index of microvascular resistance (caIMR) is a brand new method for assessing coronary microcirculation in ischemia and no obstructive coronary artery disease (INOCA). In this trial, the investigators aim to verify the safety and effectiveness of caIMR in STEMI who underwent primary PCI. The investigators will immediately measure the caIMR of patients who successfully underwent pPCI, and combine the caIMR with the long-term prognosis, to verify the prognostic performance of caIMR.

Read the detailed description

The index of microcirculatory resistance (IMR) is a readily available, wire-based approach for assessing microvascular dysfunction immediately post-stenting for STEMI. The parameter has been used to characterize MVO, was associated with infarct size, and subsequent cardiac death and heart failure. However, the application of IMR in clinical practice remains limited, primarily due to the requirement of a pressure-temperature sensor wire and hyperaemic agents, which add complexity and time.

The development of functional coronary angiography has enabled the estimation of IMR based on angiography alone. The coronary angiography-derived index of microvascular resistance (caIMR) has shown good diagnostic accuracy compared with wire-based invasive IMR. This simple alternative index showed an association with extent of MVO and was of prognostic importance. In this trial, the investigators aim to verify the safety and effectiveness of caIMR in STEMI who underwent primary PCI. The investigators will immediately measure the caIMR of patients who successfully underwent pPCI, and combine the caIMR with the long-term prognosis, to verify the prognostic performance of caIMR.

Conditions: Microvascular Coronary Artery Disease, STEMI
Being tested: Non-intervention
Keywords: STEMI, caIMR, coronary microvascular disease
Medical subject headings: ST Elevation Myocardial Infarction, Microvascular Angina

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-interventionOther
non-intervention

Study groups in NCT06118450
Study group	Role	What they receive
high caIMR		caIMR≥25 Receives: Other: Non-intervention
low caIMR		caIMR<25 Receives: Other: Non-intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Major Adverse Cardiovascular Events (MACE )
Rate of MACE. MACE was defined as a composite endpoint of cardiac death, myocardial reinfarction, readmission for heart failure, and unplanned readmission for ischemia.
Measured: 12 months

Secondary outcomes (5)

MACE
Rate of MACE. MACE was defined as a composite outcome of cardiac death, myocardial reinfarction, readmission for heart failure, and unplanned readmission for ischemia.
Measured: 1 month; 6months
Outcome events for each category
Rate of cardiac death, rate of myocardial reinfarction, rate of readmission for heart failure, and rate of unplanned readmission for ischemia.
Measured: 12 months
Stroke
incidence rate
Measured: 12 months
Malignant arrhythmia
incidence rate
Measured: 12 months
Target vessel failure (TVF)
Rate of TVF. TVF was defined as a combined outcome, consisting of revascularization, infarction and death for target vessel
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202331 May 2025

First posted7 Nov 2023
Study start1 Nov 2023
Primary completion28 Feb 2025 (estimated)
Study completion31 May 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Microvascular Coronary Artery DiseaseStudies 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: Cohort
Time perspective: Prospective
Enrolment: 335 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06118450
Sponsor's protocol ID: XYFY2023-QL152-02
Acronym: FlashIV
Status last verified: Nov 2023
First submitted: 1 Nov 2023
Last updated: 8 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Li J, Gong Y, Wang W, Yang Q, Liu B, Lu Y, Xu Y, Huo Y, Yi T, Liu J, Li Y, Xu S, Zhao L, Ali ZA, Huo Y. Accuracy of computational pressure-fluid dynamics applied to coronary angiography to derive fractional flow reserve: FLASH FFR. Cardiovasc Res. 2020 Jun 1;116(7):1349-1356. doi: 10.1093/cvr/cvz289.
PubMed 31693092
Zhang D, Lv S, Song X, Yuan F, Xu F, Zhang M, Yan S, Cao X. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention: a meta-analysis. Heart. 2015 Mar;101(6):455-62. doi: 10.1136/heartjnl-2014-306578. Epub 2015 Jan 30.
PubMed 25637372
Davies JE, Sen S, Dehbi HM, Al-Lamee R, Petraco R, Nijjer SS, Bhindi R, Lehman SJ, Walters D, Sapontis J, Janssens L, Vrints CJ, Khashaba A, Laine M, Van Belle E, Krackhardt F, Bojara W, Going O, Harle T, Indolfi C, Niccoli G, Ribichini F, Tanaka N, Yokoi H, Takashima H, Kikuta Y, Erglis A, Vinhas H, Canas Silva P, Baptista SB, Alghamdi A, Hellig F, Koo BK, Nam CW, Shin ES, Doh JH, Brugaletta S, Alegria-Barrero E, Meuwissen M, Piek JJ, van Royen N, Sezer M, Di Mario C, Gerber RT, Malik IS, Sharp ASP, Talwar S, Tang K, Samady H, Altman J, Seto AH, Singh J, Jeremias A, Matsuo H, Kharbanda RK, Patel MR, Serruys P, Escaned J. Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834. doi: 10.1056/NEJMoa1700445. Epub 2017 Mar 18.
PubMed 28317458
Lerman A, Holmes DR, Herrmann J, Gersh BJ. Microcirculatory dysfunction in ST-elevation myocardial infarction: cause, consequence, or both? Eur Heart J. 2007 Apr;28(7):788-97. doi: 10.1093/eurheartj/ehl501. Epub 2007 Mar 8.
PubMed 17347176
Bolognese L, Carrabba N, Parodi G, Santoro GM, Buonamici P, Cerisano G, Antoniucci D. Impact of microvascular dysfunction on left ventricular remodeling and long-term clinical outcome after primary coronary angioplasty for acute myocardial infarction. Circulation. 2004 Mar 9;109(9):1121-6. doi: 10.1161/01.CIR.0000118496.44135.A7. Epub 2004 Feb 16.
PubMed 14967718
Hombach V, Grebe O, Merkle N, Waldenmaier S, Hoher M, Kochs M, Wohrle J, Kestler HA. Sequelae of acute myocardial infarction regarding cardiac structure and function and their prognostic significance as assessed by magnetic resonance imaging. Eur Heart J. 2005 Mar;26(6):549-57. doi: 10.1093/eurheartj/ehi147. Epub 2005 Feb 15.
PubMed 15713695
Wu KC, Zerhouni EA, Judd RM, Lugo-Olivieri CH, Barouch LA, Schulman SP, Blumenthal RS, Lima JA. Prognostic significance of microvascular obstruction by magnetic resonance imaging in patients with acute myocardial infarction. Circulation. 1998 Mar 3;97(8):765-72. doi: 10.1161/01.cir.97.8.765.
PubMed 9498540
Eitel I, de Waha S, Wohrle J, Fuernau G, Lurz P, Pauschinger M, Desch S, Schuler G, Thiele H. Comprehensive prognosis assessment by CMR imaging after ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2014 Sep 23;64(12):1217-26. doi: 10.1016/j.jacc.2014.06.1194.
PubMed 25236513
Cuculi F, De Maria GL, Meier P, Dall'Armellina E, de Caterina AR, Channon KM, Prendergast BD, Choudhury RP, Forfar JC, Kharbanda RK, Banning AP. Impact of microvascular obstruction on the assessment of coronary flow reserve, index of microcirculatory resistance, and fractional flow reserve after ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2014 Nov 4;64(18):1894-904. doi: 10.1016/j.jacc.2014.07.987. Epub 2014 Oct 27.
PubMed 25444143
De Maria GL, Alkhalil M, Wolfrum M, Fahrni G, Borlotti A, Gaughran L, Dawkins S, Langrish JP, Lucking AJ, Choudhury RP, Porto I, Crea F, Dall'Armellina E, Channon KM, Kharbanda RK, Banning AP. Index of Microcirculatory Resistance as a Tool to Characterize Microvascular Obstruction and to Predict Infarct Size Regression in Patients With STEMI Undergoing Primary PCI. JACC Cardiovasc Imaging. 2019 May;12(5):837-848. doi: 10.1016/j.jcmg.2018.02.018. Epub 2018 Apr 18.
PubMed 29680355
Fahrni G, Wolfrum M, De Maria GL, Cuculi F, Dawkins S, Alkhalil M, Patel N, Forfar JC, Prendergast BD, Choudhury RP, Channon KM, Banning AP, Kharbanda RK. Index of Microcirculatory Resistance at the Time of Primary Percutaneous Coronary Intervention Predicts Early Cardiac Complications: Insights From the OxAMI (Oxford Study in Acute Myocardial Infarction) Cohort. J Am Heart Assoc. 2017 Nov 7;6(11):e005409. doi: 10.1161/JAHA.116.005409.
PubMed 29113999
Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.
PubMed 23681066
Fearon WF, Shah M, Ng M, Brinton T, Wilson A, Tremmel JA, Schnittger I, Lee DP, Vagelos RH, Fitzgerald PJ, Yock PG, Yeung AC. Predictive value of the index of microcirculatory resistance in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2008 Feb 5;51(5):560-5. doi: 10.1016/j.jacc.2007.08.062.
PubMed 18237685
McGeoch R, Watkins S, Berry C, Steedman T, Davie A, Byrne J, Hillis S, Lindsay M, Robb S, Dargie H, Oldroyd K. The index of microcirculatory resistance measured acutely predicts the extent and severity of myocardial infarction in patients with ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2010 Jul;3(7):715-22. doi: 10.1016/j.jcin.2010.04.009.
PubMed 20650433
Ai H, Feng Y, Gong Y, Zheng B, Jin Q, Zhang HP, Sun F, Li J, Chen Y, Huo Y, Huo Y. Coronary Angiography-Derived Index of Microvascular Resistance. Front Physiol. 2020 Dec 16;11:605356. doi: 10.3389/fphys.2020.605356. eCollection 2020.
PubMed 33391020

Want to know more?

Lu Yuan

86-13952110901

luyuan329@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Online Coronary Angiography-Derived Index of Microcirculatory Resistance in STEMI Patients (Flash IV)
ClinicalTrials.gov ID: NCT06118450
Acronym / sponsor ID: FlashIV / XYFY2023-QL152-02
Conditions: Microvascular Coronary Artery Disease, STEMI
Keywords: STEMI, caIMR, coronary microvascular disease
Study type: Observational
Recruitment status: Unknown status
Enrolment: 335 participants (estimated)
Lead sponsor: The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
Collaborators: RainMed Medical Group
Study start: 1 Nov 2023 (actual)
Primary completion: 28 Feb 2025 (estimated)
Study completion: 31 May 2025 (estimated)
First posted: 7 Nov 2023 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
high caIMR	–	Other: Non-interventioncaIMR≥25
low caIMR	–	Other: Non-interventioncaIMR<25

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Aged between 18 and 80, regardless of gender. Initially diagnosed as STEMI and underwent primary PCI.

Key inclusion criteria (3 listed)

Aged between 18 and 80, regardless of gender;
Initially diagnosed as STEMI and underwent primary PCI;
Voluntarily participated in this trial and signed the informed consent form.

Key exclusion criteria (15 listed)

Coronary angiography shows that PCI is not suitable;
Past history of coronary artery bypass grafting (CABG);
Past history of heart failure;
Past history of myocardial infarction;
Primary or secondary cardiomyopathy or heart valve disease;

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	high caIMR, low caIMR

Primary outcome

Major Adverse Cardiovascular Events (MACE )
Time frame: 12 months
Rate of MACE. MACE was defined as a composite endpoint of cardiac death, myocardial reinfarction, readmission for heart failure, and unplanned readmission for ischemia.

5 secondary outcomes

MACE
Time frame: 1 month; 6months
Outcome events for each category
Time frame: 12 months
Stroke
Time frame: 12 months
Malignant arrhythmia
Time frame: 12 months
Target vessel failure (TVF)
Time frame: 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
Background: PubMed 31693092Li J, Gong Y, Wang W, Yang Q, Liu B, Lu Y, Xu Y, Huo Y, Yi T, Liu J, Li Y, Xu S, Zhao L, Ali ZA, Huo Y. Accuracy of computational pressure-fluid dynamics applied to coronary angiography to derive fractional flow reserve: FLASH FFR. Cardiovasc Res. 2020 Jun 1;116(7):1349-1356. doi: 10.1093/cvr/cvz289.
Background: PubMed 25637372Zhang D, Lv S, Song X, Yuan F, Xu F, Zhang M, Yan S, Cao X. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention: a meta-analysis. Heart. 2015 Mar;101(6):455-62. doi: 10.1136/heartjnl-2014-306578. Epub 2015 Jan 30.
Background: PubMed 28317458Davies JE, Sen S, Dehbi HM, Al-Lamee R, Petraco R, Nijjer SS, Bhindi R, Lehman SJ, Walters D, Sapontis J, Janssens L, Vrints CJ, Khashaba A, Laine M, Van Belle E, Krackhardt F, Bojara W, Going O, Harle T, Indolfi C, Niccoli G, Ribichini F, Tanaka N, Yokoi H, Takashima H, Kikuta Y, Erglis A, Vinhas H, Canas Silva P, Baptista SB, Alghamdi A, Hellig F, Koo BK, Nam CW, Shin ES, Doh JH, Brugaletta S, Alegria-Barrero E, Meuwissen M, Piek JJ, van Royen N, Sezer M, Di Mario C, Gerber RT, Malik IS, Sharp ASP, Talwar S, Tang K, Samady H, Altman J, Seto AH, Singh J, Jeremias A, Matsuo H, Kharbanda RK, Patel MR, Serruys P, Escaned J. Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834. doi: 10.1056/NEJMoa1700445. Epub 2017 Mar 18.
Background: PubMed 17347176Lerman A, Holmes DR, Herrmann J, Gersh BJ. Microcirculatory dysfunction in ST-elevation myocardial infarction: cause, consequence, or both? Eur Heart J. 2007 Apr;28(7):788-97. doi: 10.1093/eurheartj/ehl501. Epub 2007 Mar 8.
Background: PubMed 14967718Bolognese L, Carrabba N, Parodi G, Santoro GM, Buonamici P, Cerisano G, Antoniucci D. Impact of microvascular dysfunction on left ventricular remodeling and long-term clinical outcome after primary coronary angioplasty for acute myocardial infarction. Circulation. 2004 Mar 9;109(9):1121-6. doi: 10.1161/01.CIR.0000118496.44135.A7. Epub 2004 Feb 16.
Background: PubMed 15713695Hombach V, Grebe O, Merkle N, Waldenmaier S, Hoher M, Kochs M, Wohrle J, Kestler HA. Sequelae of acute myocardial infarction regarding cardiac structure and function and their prognostic significance as assessed by magnetic resonance imaging. Eur Heart J. 2005 Mar;26(6):549-57. doi: 10.1093/eurheartj/ehi147. Epub 2005 Feb 15.
Background: PubMed 9498540Wu KC, Zerhouni EA, Judd RM, Lugo-Olivieri CH, Barouch LA, Schulman SP, Blumenthal RS, Lima JA. Prognostic significance of microvascular obstruction by magnetic resonance imaging in patients with acute myocardial infarction. Circulation. 1998 Mar 3;97(8):765-72. doi: 10.1161/01.cir.97.8.765.
Background: PubMed 25236513Eitel I, de Waha S, Wohrle J, Fuernau G, Lurz P, Pauschinger M, Desch S, Schuler G, Thiele H. Comprehensive prognosis assessment by CMR imaging after ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2014 Sep 23;64(12):1217-26. doi: 10.1016/j.jacc.2014.06.1194.
Background: PubMed 25444143Cuculi F, De Maria GL, Meier P, Dall'Armellina E, de Caterina AR, Channon KM, Prendergast BD, Choudhury RP, Forfar JC, Kharbanda RK, Banning AP. Impact of microvascular obstruction on the assessment of coronary flow reserve, index of microcirculatory resistance, and fractional flow reserve after ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2014 Nov 4;64(18):1894-904. doi: 10.1016/j.jacc.2014.07.987. Epub 2014 Oct 27.
Background: PubMed 29680355De Maria GL, Alkhalil M, Wolfrum M, Fahrni G, Borlotti A, Gaughran L, Dawkins S, Langrish JP, Lucking AJ, Choudhury RP, Porto I, Crea F, Dall'Armellina E, Channon KM, Kharbanda RK, Banning AP. Index of Microcirculatory Resistance as a Tool to Characterize Microvascular Obstruction and to Predict Infarct Size Regression in Patients With STEMI Undergoing Primary PCI. JACC Cardiovasc Imaging. 2019 May;12(5):837-848. doi: 10.1016/j.jcmg.2018.02.018. Epub 2018 Apr 18.
Background: PubMed 29113999Fahrni G, Wolfrum M, De Maria GL, Cuculi F, Dawkins S, Alkhalil M, Patel N, Forfar JC, Prendergast BD, Choudhury RP, Channon KM, Banning AP, Kharbanda RK. Index of Microcirculatory Resistance at the Time of Primary Percutaneous Coronary Intervention Predicts Early Cardiac Complications: Insights From the OxAMI (Oxford Study in Acute Myocardial Infarction) Cohort. J Am Heart Assoc. 2017 Nov 7;6(11):e005409. doi: 10.1161/JAHA.116.005409.
Background: PubMed 23681066Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.
Individual participant dataSharing planned: Undecided

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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.

Lu Yuan contact

86-13952110901

luyuan329@163.com

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Microvascular Coronary Artery Disease and STEMI, run by The Affiliated Hospital of Xuzhou Medical University at 8 sites 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 3 inclusion and 15 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 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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 Lu Yuan (86-13952110901, luyuan329@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiovascular Events (MACE ) (time frame: 12 months). 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 NCT06118450, which also lists 18 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 8 Nov 2023.