Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular DysfunctionT-MICRONCT03504202

Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)

A study testing Trimetazidine in people with Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction, run by Shanghai 10th People's Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction
What is being tested?: Trimetazidine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: 1 Mar 2019to 1 Sep 2020
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age≥18 years
Typical angina symptoms
Coronary angiography or coronary computed tomography examination showed no significant epicardial coronary artery stenosis (<20%)
Never used trimetazidine
The CFR measured by the pressure guide wire is less than 2.0
agree to participant the study and sign informed written consent
available for six months follow up

Who cannot join

Severe liver and kidney disease
Contraindications of Trimetazidine
Use of CYP3A inhibitors, such as diltiazem, verapamil, and other drugs that may affect CFR measurements
QT interval extension
Atrial fibrillation or left bundle branch block
Left ventricular systolic dysfunction (EF <55%)

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Coronary artery fistula
Myocardial bridge
Non-cardiogenic chest pain and other heart diseases
Severe heart valve disease
Diabetes
Recent ACS( Acute coronary syndrome)
Pregnancy
Failed to complete inspection

About this study

This is a prospective study which aims to explore the effect of Trimetazidine on the improvement of coronary microvascular dysfunction in patients with INOCA (ischemia and no obstructive coronary artery disease). Enrolled patients will be assessed SAQ(Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR(coronary flow reserve) .CFR inspection with D-SPECT and pressure guide wire.Patients will receive six months Trimetazidine(35mg tid) after enrollment. And their SAQ (Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR will be followed up.

Conditions: Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction
Being tested: Trimetazidine

What participants receive

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

TrimetazidineDrug
After enrollment, experimental group will receive Trimetazidine(35mg tid) for six months .

Study groups in NCT03504202
Study group	Role	What they receive
Trimetazidine	Experimental	Not described Receives: Drug: Trimetazidine

What is being measured

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

Coronary flow reserve (CFR) improves
Measured: six months

Secondary outcomes (2)

Seattle angina score or Canadian angina grade drops
Measured: six months
Six-minute walking experiment improves
Measured: six months

Timeline

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

1 Mar 20191 Sep 2020

First posted20 Apr 2018
Study start1 Mar 2019 (estimated)
Primary completion1 Apr 2020 (estimated)
Study completion1 Sep 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular DysfunctionStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03504202
Sponsor's protocol ID: T-MICRO01
Acronym: T-MICRO
Status last verified: Oct 2018
First submitted: 11 Apr 2018
Last updated: 25 Oct 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)
ClinicalTrials.gov ID: NCT03504202
Acronym / sponsor ID: T-MICRO / T-MICRO01
Conditions: Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 10 participants (estimated)
Lead sponsor: Shanghai 10th People's HospitalUniversity, hospital or other
Study start: 1 Mar 2019 (estimated)
Primary completion: 1 Apr 2020 (estimated)
Study completion: 1 Sep 2020 (estimated)
First posted: 20 Apr 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Trimetazidine	Experimental	Drug: Trimetazidine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

age≥18 years
Typical angina symptoms
Coronary angiography or coronary computed tomography examination showed no significant epicardial coronary artery stenosis (<20%)
Never used trimetazidine
The CFR measured by the pressure guide wire is less than 2.0

Key exclusion criteria (14 listed)

Severe liver and kidney disease
Contraindications of Trimetazidine
Use of CYP3A inhibitors, such as diltiazem, verapamil, and other drugs that may affect CFR measurements
QT interval extension
Atrial fibrillation or left bundle branch block

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
TrimetazidineAfter enrollment, experimental group will receive Trimetazidine(35mg tid) for six months .	Drug	Trimetazidine

Primary outcome

Coronary flow reserve (CFR) improves
Time frame: six months

2 secondary outcomes

Seattle angina score or Canadian angina grade drops
Time frame: six months
Six-minute walking experiment improves
Time frame: six months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 14 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 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Coronary flow reserve (CFR) improves (time frame: six 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 NCT03504202.

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 25 Oct 2018.