UMIN-CTR Clinical Trial

Public title

99mTc-sestamibi myocardial scintigraphy in cardiac disease patients treated with cardiac rehabilitation

Acronym

99mTc-sestamibi myocardial scintigraphy in cardiac disease patients treated with cardiac rehabilitation

Scientific Title

99mTc-sestamibi myocardial scintigraphy in cardiac disease patients treated with cardiac rehabilitation

Scientific Title:Acronym

99mTc-sestamibi myocardial scintigraphy in cardiac disease patients treated with cardiac rehabilitation

Region

Japan

Condition

Cardiac disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of cardiac rehabilitation using the 99mTc-sestamibi myocardial and leg scintigrams in patients with cardiac disease. The difference of effect from cardiac rehabilitation was also assessed.

Basic objectives2

Bio-availability

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1.Hematological evaluation
Creatinine kinase (CK), CK-myoglobin binding (CK-MB), brain natriuretic peptide (BNP), creatinine (Cr)
2.Myocardial planner images
Planner images obtained in the early and delayed phase after tracer injection
3.Myocardial single photon emission computed tomography (SPECT)
Short-axis SPECT images at rest
4.Gated SPECT
Left ventricular (LV) end systolic and diastolic volumes, LV ejection fraction, LV diastolic function

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with cardiac disease who were successfully treated in the acute phase and who were able to participate cardiac rehabilitation were enrolled.

Key exclusion criteria

Patients who had acute coronary syndrome within the last half year, those with severe hepatic and/or renal impairment, those with inappropriate arrhythmia, such as premature ventricular contraction (PVC) and atrial fibrillation, for electrocardiography-gated SPECT data collection, and small heart patients.

Target sample size

400

Name of lead principal investigator

1st name	Akashi
Middle name	J.
Last name	Yoshihiro

Organization

St.Marianna Uneversity School of Medicine

Division name

Division of cardiology,Department of Internal Medicine

Zip code

2168511

Address

2-16-1 sugao , miyamae-ku , kawasaki city , kanagawa , Japan

TEL

044-977-8111

Email

nmmfy630@yahoo.co.jp

Name of contact person

1st name	Kohei
Middle name
Last name	Ashikaga

Organization

St.Marianna Uneversity School of Medicine

Division name

Division of cardiology,Department of Internal Medicine

Zip code

2168511

Address

2-16-1 sugao , miyamae-ku , kawasaki city , kanagawa , Japan

TEL

044-977-8111

Homepage URL

Email

k2ashikaga@marianna-u.ac.jp

Institute

Division of cardiology,Department of Internal Medicine. St.Marianna Uneversity School of Medicine

Institute

Department

Personal name

Organization

Division of cardiology,Department of Internal Medicine. St.Marianna Uneversity School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

St. Maryanna University School of Medicine Bioethics Committee

Address

2-16-1, sugao, Miyamae-ku, Kawasaki city, Kanagawa

Tel

0449778111

Email

k2ashikaga@marianna-u.ac.jp

Secondary IDs

YES

Study ID_1

1971

Org. issuing International ID_1

St.Marianna Uneversity School of Medicine

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

聖マリアンナ医科大学病院

Date of disclosure of the study information

2011

Year

12

Month

05

Day

URL releasing protocol

https://link.springer.com/article/10.1007%2Fs12149-011-0519-6

Publication of results

Published

URL related to results and publications

https://link.springer.com/article/10.1007%2Fs12149-011-0519-6

Number of participants that the trial has enrolled

61

Results

PCI was performed 8.3h after AMI onset. At 6M, the early H/M ratio, delayed H/M ratio, global WR, culprit WR, and delayed ES were alleviated. At 0M, the peak CK-MB level correlated with the delayed H/M ratio, global WR, culprit WR, early ES, delayed ES, early SS, and delayed SS. At 6M, the peak CK-MB level correlated with the delayed H/M ratio, global WR, culprit WR, early ES, delayed ES, early SS, and delayed SS.

Results date posted

2021

Year

12

Month

13

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

This study aimed to clarify the correlation between the myocardial washout rate (WR) of technetium-99m hexakis 2-methoxy-isobutyl-isonitrile ((99m)Tc-sestamibi) and cardiac enzyme levels in patients with acute myocardial infarction (AMI) 6 months after the onset.

Participant flow

Once a patient was diagnosed with AMI, he/she was immediately transferred to the cardiac catheter laboratory to undergo PCI. A thrombus-aspiration catheter was inserted to penetrate the occluded lesions. Blood samples were collected every 3 h after PCI to obtain the peak levels of cardiac enzymes. BNP levels were measured at 2 weeks (0 M; the acute phase) and at 6 months (6 M; the chronic phase) after the onset of AMI. None of the patients experienced worsening of their symptoms or required hospitalization because of AMI-related complications during the study period.

Adverse events

None

Outcome measures

Creatinine kinase MB isoenzyme (CK-MB) levels were measured every 3 h. (99m)Tc-sestamibi myocardial scintigraphic images were obtained at the early (30 min) and delayed (4 h) phases after tracer injection for calculating heart-to-mediastinum (H/M) ratios and global WRs at 2 weeks (0 M) and 6 months (6 M) after the onset of AMI. Regional WRs in the culprit lesions (culprit WR) and the extent score (ES) and severity score (SS) of myocardial damage were also calculated.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2011

Year

10

Month

12

Day

Date of IRB

2011

Year

10

Month

12

Day

Anticipated trial start date

2011

Year

11

Month

01

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

In patients with chronic heart failure, the washout rates (WR) of 99mTc-sestamibi at rest are correlated with disease severity and myocardial damage. Our previous study has demonstrated that 99mTc-sestamibi myocardial WR is associated with the increased cardiac enzyme levels and myocardial infarct size in patients with acute myocardial infarction. We have thus concluded that WR calculated from 99mTc-sestamibi scintigrams possibly predicts disease severity and prognosis in patients with cardiac disease.
It is well known the benefits of cardiac rehabilitation which improves exercise capacity and peripheral skeletal muscle function in patients with various heart diseases. Peripheral skeletal muscle function is generally evaluated by the strength of knee extensor muscle, quadriceps femoris muscle mass and muscle biopsies. It has been required to establish a new method for assessing muscle function because muscle biopsies are highly invasive and painful.
99mTc-sestamibi scintigraphy is mainly performed for the assessment of the myocardium. 99mTc-sestamibi accumulation in myocytes reflects mitochondrial function. If mitochondrial function in the lower extremities is increased by cardiac rehabilitation, the uptake of 99mTc-sestamibi will also be increased. We therefore presume that 99mTc-MIBI scintigraphy can evaluate noninvasively not only cardiac function but also peripheral skeletal muscle function at rest.

* A prospective study
* A random sample

Registered date

2011

Year

12

Month

05

Day

Last modified on

2021

Year

12

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007777